Biosimilars Deals 2021 Archives

Pearce IP BioBlast® for the week ending 21 November 2025

Nov 25, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 21 November 2025 are set out below:

Adalimumab, Omalizumab, Ustekinumab

19 November 2025 | AU | Adalimumab, Omalizumab and Ustekinumab Biosimilars on March 2026 PBAC Agenda

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be… Read more here.

Aflibercept

24 November 2025 | EU | UK | First Wave of European Biosimilar Aflibercept Launches Commences, with Sandoz’s Afqlir® on the UK Market
On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets… Read more here.

19 November 2025 | US | New Indication Alert: FDA Approves Regeneron’s Eylea HD® for RVO and 4-Weekly Dosing
On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein… Read more here.

Denosumab

20 November 2025 | US | Accord’s Denosumab Biosimilars FDA Approved

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva®… Read more here.

14 November 2025 | US | Amgen Commences 11th BPCIA Denosumab Litigation Against Alkem
On 14 November 2025, Amgen filed BPCIA proceedings in the US District Court for the District of New Jersey against Alkem Laboratories and its subsidiaries… Read more here.

Golimumab

20 November 2025 | EU | Alvotech/Advanz Achieve First EU-Approved Golimumab Biosimilar
On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic… Read more here.

Infliximab

18 November 2025 | EU | Celltrion Secures First Approval of Infliximab IV Liquid Formulation
On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the… Read more here.

Omalizumab

18 November 2025 | EU | Celltrion’s Biosimilar Omalizumab EU Approved in New Dosage Form

On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®… Read more here.

Pembrolizumab

19 November 2025 | EU | MSD’s Subcutaneous Keytruda® Approved in Europe
On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed… Read more here.

17 November 2025 | US | PTAB Invalidates 9 Johns Hopkins US Pembrolizumab Patents in MSD IPRs
Between 28 October 2025 and 17 November 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s… Read more here.

Ranibizumab

20 November 2025 | DE | Formycon/Bioeq & Sandoz Partner for German Launch of Biosimilar Ranibizumab
On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s… Read more here.

19 November 2025 | US | Xbrane to Resubmit Ranibizumab Biosimilar BLA in March 2026
On 19 November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter… Read more here.

Trastuzumab deruxtecan

21 November 2025 | Samsung Bioepis Reportedly Developing Biosimilar to AZ/Daiichi’s Enhertu®
On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca… Read more here.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

First Wave of European Biosimilar Aflibercept Launches Commences, with Sandoz’s Afqlir® on the UK Market

Nov 24, 2025

On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.

Afqlir® was the second aflibercept biosimilar approved in Europe in November 2024 and received marketing authorisation in the UK in January 2025. It is approved for all indications of Eylea® and is available in a 2 mg vial kit and pre-filled syringe for intravitreal injection.

The European launch of Afqlir® follows the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept). It is expected that other European aflibercept biosimilar launches will be announced shortly.

Aflibercept biosimilars currently approved in Europe include Biocon’s Yesafili® (September 2023), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025). Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

Litigation will continue to hold up European launches for some biosimilar sponsors. For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries. The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025. In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

Pearce IP Setting the Standard for Employee Reproductive Health Benefits

Nov 24, 2025

Two years ago, Pearce IP made the decision to put its employee’s first by introducing a raft of reproductive leave options for all permanent employees.

With a workforce that’s 𝟴𝟴% 𝗳𝗲𝗺𝗮𝗹𝗲 and witnessing the impact of reproductive health issues at all ages, it made sense for Pearce IP to provide leave over and above statutory requirements (where available) that was important to our staff including:

Generous parental leave: because we celebrate the birth of an employee’s baby with them;
Still birth and miscarriage leave (up to 4 weeks paid leave; with 12 months maternity leave for the loss of a baby): because an employee’s loss and grief matters to us;
Fertility treatment leave (5 paid days/year, or 19 (2 hour) blocks): because we support and care for our employee’s who wish to have a family; and
Menstrual and Menopause leave (6 paid days/year): because menstruation/menopause is not an illness and should not cut into your sick leave;

In addition we provide:

Birthday leave, so Pearce IP employees never work on their birthday!
Sorry Business/Tangihanga leave, so employees can grieve in a culturally appropriate way;
5 weeks paid annual leave each and every year for employees with more than 5 years service,;
$10K cash at 10 years service;
Further education support and study/exam leave, so that every employee can reach their potential.

We 𝗟𝗢𝗩𝗘 saying 𝘺𝘦𝘴 to leave when an employee has a migraine due to their period – no questions asked.

We 𝗟𝗢𝗩𝗘𝗗 saying 𝘺𝘦𝘴 to an employee who travelled overseas for fertility treatment leave this year.

Our turnover is well below industry average, and we have an outstanding and capable workforce who appreciate and value our generous leave policies.

Learn more about Pearce IP’s award-winning culture and employee benefits: Pearce IP is Australasian Lawyer and NZ Lawyer’s 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Samsung Bioepis Reportedly Developing Biosimilar to AZ/Daiichi’s Enhertu®

Nov 21, 2025

On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan). According to the report, the biosimilar is still in the early development stage, in preparation for preclinical trials.

The report also suggests that Samsung Bioepis is developing biosimilars to MSD’s Keytruda® (pembrolizumab), Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab). Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) on 5 April 2024. Samsung Bioepis has not issued press releases to date in relation to the development of any of the other biosimilars referred to in The Asia News Daily report.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

Formycon/Bioeq & Sandoz Partner for German Launch of Biosimilar Ranibizumab

Nov 20, 2025

On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s Lucentis®, in Germany. Sandoz is marketing the product, which is indicated for nAMD, macular oedema, diabetic retinopathy and other visual impairments, under licence from Bioeq, a joint venture between Formycon and Polpharma Biologics.

Epruvy® was approved by the European Medicines Agency in September 2024 (as Ranibizumab Midas), following a positive CHMP opinion in July 2024, and is available in vial and pre-filled syringe (PFS) dosage forms. According to Formycon, the PFS is a “first-of-its kind ophthalmic biosimilar presentation in Germany”.

Formycon/Teva’s Lucentis® biosimilar, FYB201/Ranivisio®, was first approved in Europe in August 2022 and has been commercialised in the region in vial form by Teva since 2022. In October 2025, Formycon/Teva announced the launch of the PFS form in France, with additional countries to follow in a staggered approach. FYB201 was approved in the UK in May 2022 (marketed as Ongavia® by Teva), the US in August 2022 (marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada in December 2023 (marketed as Ranopto™ by Teva) and MENA in March 2024 (marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars in Europe include Samsung Bioepis’ Byooviz® (EU-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

Alvotech/Advanz Achieve First EU-Approved Golimumab Biosimilar

Nov 20, 2025

On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic Area for Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab). The approval covers both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL) of Gobivaz® for treating adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, and ulcerative colitis, and for treating juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate.

Gobivaz® is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.

AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma. Also in September 2025, Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after Alvotech/Advanz’s European MAA for that product was the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024. Gobivaz® was approved in the UK in November 2025.

In the US, Alvotech/Teva’s Biologics License Application (BLA) for AVT05 was accepted by the FDA in January 2025. The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.

A golimumab biosimilar, BAT2506, is also being developed by Bio-Thera, with an MAA for the product accepted in Europe in February 2025 (where it is being commercialised by STADA under a May 2024 agreement), and a BLA accepted for FDA review in July 2025 (with Accord responsible for US commercialisation). Bio-Thera has entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 2025).

Accord’s Denosumab Biosimilars FDA Approved

Nov 20, 2025

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications. Accord plans to launch the denosumab biosimilars in the US in 2026.

In November 2024, Amgen commenced BPCIA proceedings against Accord/Intas, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture. The litigation followed Accord/Intas’ submission of its abbreviated BLAs for its denosumab biosimilars. The US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025 (subject to regulatory approval).

There are a number of denosumab biosimilars approved and launched in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).

Xbrane to Resubmit Ranibizumab Biosimilar BLA in March 2026

Nov 19, 2025

On 19 November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025. Xbrane expects to be able to resubmit its BLA in March 2026 following completion of corrective action to be taken at the production site of Xbrane’s relevant contract manufacturer.

According to Xbrane, following resubmissions of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in September 2026.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, who will be responsible for commercialisation in the US, likely under the Lucamzi™ brand.

There are currently two ranibizumab biosimilars approved in the US. The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Formycon/Sandoz’s Cimerli® (August 2022).

MSD’s Subcutaneous Keytruda® Approved in Europe

Nov 19, 2025

On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed in the EU as Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph). The marketing authorisation covers all 33 previously approved adult indications for Keytruda® (pembrolizumab) in Europe and follows a positive recommendation from the EMA’s CHMP in September 2025.

The subcutaneous formulation was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.

MSD was sued by Halozyme in the US on 24 April 2025 in relation to SC pembrolizumab, with Halozyme alleging that it infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery platform. The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents. At the time, a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of 14 of Halozyme’s US patents. The petitions were filed between November 2024 and June 2025 and all 14 have been instituted. The patents at issue are: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185, US 12037618, US 12091692, US 12077791, US 12195773 and US 12264345.

New Indication Alert: FDA Approves Regeneron’s Eylea HD® for RVO and 4-Weekly Dosing

Nov 19, 2025

On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. A 4-weekly dosing option has also been approved for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).

Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® is still on hold while Regeneron seeks to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA. Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA. Regeneron plans to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.

Regeneron’s Eylea HD® was approved in the US in a vial form for nAMD, DME and DR in August 2023. Regeneron has submitted an application to include an additional vial filler in its BLA, with an FDA decision regarding this new vial filler expected by late December 2025.

Eylea® 8mg (as the product is known in other jurisdictions) is approved for nAMD and DME (as intravitreal injection) including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024). Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025). Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.

Adalimumab, Omalizumab and Ustekinumab Biosimilars on March 2026 PBAC Agenda

Nov 19, 2025

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; and
Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.

Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025. In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS. Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).

In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab). Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025. The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia. While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing. As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025. Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

Pearce IP BioBlast® for the week ending 14 November 2025

Nov 18, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 14 November 2025 are set out below:

Bevacizumab

13 November 2025 | US | FDA Accepts Outlook Therapeutics’ BLA for Ophthalmic Bevacizumab

On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation… Read more here.

Denosumab

12 November 2025 | UK | Henlius’ MAAs for Biosimilar Denosumab Accepted in UK

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing… Read more here.

Denosumab, Insulin Glargine

14 November 2025 | EU | CHMP Positive Opinions for Denosumab & Insulin Glargine Biosims

At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for… Read more here.

Guselkumab

11 November 2025 | GB-SCT | J&J’s Guselkumab Accessible through NHS Scotland for Crohn’s and UC
On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in… Read more here.

Natalizumab

17 November 2025 | US | Sandoz Launches First Natalizumab Biosimilar in the US
On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab). Tyruko® is the only natalizumab… Read more here.

Ocrelizumab

6 November 2025 | RU | Biocad Commences Ph III Clinical Trial of Biosimilar Ocrelizumab

On 6 November 2025, Biocad announced that it is commencing enrolment for a Phase III clinical trial of BCD-281, biosimilar to Roche’s Ocrevus® (ocrelizumab)… Read more here.

Pembrolizumab

11 November 2025 | VN | Russian Pembrolizumab Biosimilar Approved in Vietnam
On 11 November 2025, Viet Nam News, reported that the Vietnam Ministry of Health has granted marketing authorisation for Pembroria™, biosimilar to MSD’s… Read more here.

Pertuzumab

13 November 2025 | US | Shanghai Henlius Announces First US Approved Interchangeable Biosimilar Pertuzumab
On 13 November 2025, the FDA announced that it has approved Shanghai Henlius’ Poherdy™ (formerly HLX11, pertuzumab-dpzb) as an interchangeable… Read more here.

12 November 2025 | Sandoz & EirGenix Global Deal for Biosimilar Pertuzumab
On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta®… Read more here.

Secukinumab

10 November | SE ASIA | Bio-Thera & Dr Reddy’s Partner on Secukinumab Biosimilar for SE Asia
On 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to… Read more here.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

Celltrion’s Biosimilar Omalizumab EU Approved in New Dosage Form

Nov 18, 2025

On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab). According to Celltrion, the additional strength of Omlyclo® “can significantly decrease the frequency of injections and reduce injection burden and discomfort without compromising efficacy and safety”.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.

Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025. Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).

Omalizumab biosimilars are also under development by Alvotech/Kashiv, Aurobindo, Teva and Glenmark. In October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for its omalizumab biosimilar, AVT23.

Celltrion Secures First Approval of Infliximab IV Liquid Formulation

Nov 18, 2025

On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the powder formulation, including rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. According to Celltrion, the product is the world’s first liquid formulation of IV infliximab.

Celltrion’s Remsima®, biosimilar to Janssen’s Remicade® (infliximab), has been approved in Europe since 2013 and was launched in major European countries in early 2015. Subcutaneous infliximab (Remsima™ SC) first received European approval in November 2019 and was launched in the EU in 2020). In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US.

PTAB Invalidates 9 Johns Hopkins US Pembrolizumab Patents in MSD IPRs

Nov 17, 2025

Between 28 October 2025 and 17 November 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s (JHU’s) 10,934,356 (IPR2024-00622), 11,325,974 (IPR2024-00623), 11,325,975 (IPR2024-00624) and 11,643,462 (IPR2024-00648) in four inter partes review proceedings (IPRs) brought by MSD. Following invalidation of five JHU US patents in June 2025 and September 2025, this means MSD has now succeeded in all nine IPRs that it filed in relation to JHU US pembrolizumab patents in 2023-2024. JHU has filed notices of appeal to the US Court of Appeals for the Federal Circuit in relation to each of the PTAB decisions.

The nine JHU patents challenged by MSD relate to the use of pembrolizumab in treating cancer patients with high mutational burdens, such as those found in microsatellite instability high (MSI) or DNA mismatch repair deficient cancer (dMMR). In each case, the PTAB found that the patents were invalid for lack of novelty and/or obviousness based on prior art, including a record of a JHU phase 2 clinical trial of Keytruda® (pembrolizumab) in MSI/dMMR cancer.

In November 2022, MSD filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel. Based on the complaint, the dispute arose out of a contract between MSD and JHU to design and conduct a clinical trial on administration regimes for Keytruda® (pembrolizumab) in cancer patients with certain genetic biomarkers. JHU filed a counter-claim on 12 April 2023, including alleging infringement of patents subject to the IPR proceedings referred to above. The US Court proceeding has been stayed pending the outcome of the IPRs. No trial date has been scheduled.

Sandoz Launches First Natalizumab Biosimilar in the US

Nov 17, 2025

On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab). Tyruko® is the only natalizumab biosimilar approved (August 2023) and launched in the US and is available for all reference indications.

Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019. As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Tyruko® was approved in Europe (September 2023) and Australia (April 2025) and was recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) under the same circumstances as Biogen’s Tysabri® in April 2025.

Amgen Commences 11th BPCIA Denosumab Litigation Against Alkem

Nov 14, 2025

On 14 November 2025, Amgen filed BPCIA proceedings in the US District Court for the District of New Jersey against Alkem Laboratories and its subsidiaries, Ascend Laboratories and Enzene Biosciences, alleging infringement of 35 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

According to Amgen’s complaint, the litigation arises out of a submission to the FDA of a Biologics License Application in relation to Alkem/Ascend’s biosimilars to Amgen’s Prolia® and Xgeva® (denosumab).

The filing of the new complaint means Amgen currently has five US proceedings pending regarding denosumab biosimilars, including lawsuits against Hikma/Gedeon Richter and Shanghai Henlius/Organon, commenced on 25 June 2025, and against Alvotech/Dr Reddy’s and Amneal/mAbxience, commenced on 6 November 2025. Amgen has settled a further six US proceedings relating to denosumab biosimilars with:

Sandoz: proceedings commenced in May 2023, were resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025;
Fresenius Kabi: proceedings commenced in October 2024 were resolved by a global settlement, resulting in the launch of Fresenius’ Conexxence® and Bomyntra® in early July 2025;
Celltrion: US proceedings settled in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025;
Accord and Intas: US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025;
Samsung Bioepis settled in early September 2025, with the terms of that settlement, including launch dates for Samsung Bioepis’ denosumab biosimilars, remaining confidential; and
Biocon: US proceedings commenced on 30 June 2025 were settled shortly thereafter, permitting Biocon’s 1 October 2025 launch of Bosaya™ and Aukelso™.

Earlier in November 2025, the European Medicine Agency’s CHMP adopted a positive opinion for Enzene/Theramex’s Osqay®, biosimilar to Amgen’s Prolia® (denosumab). Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia.

CHMP Positive Opinions for Denosumab & Insulin Glargine Biosims

Nov 14, 2025

At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilars:

Enzene/Theramex’s Osqay®, biosimilar to Amgen’s Prolia® (denosumab). Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia; and
Gan & Lee Pharmaceuticals’ Ondibta®, biosimilar to Sanofi’s Lantus® (insulin glargine).

There are a number of denosumab biosimilars already approved in Europe although none have launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).

The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.

Insulin glargine biosimilars have been approved in Europe since 2014 (the first was Eli Lilly’s Abasaglar®).

Naomi Pearce One of 36 Ranked by IAM in Global Leaders 2026

Nov 13, 2025

Pearce IP’s CEO and Founder Naomi Pearce, has been recognised in IAM Global Leaders 2026. IAM Global Leaders showcases patent leaders selected from the gold tier of IAM Patent 1000 who “merit special attention – not only because of their expertise and experience …. but also for their ability to innovate, inspire and go above and beyond to deliver value for their clients”.

Naomi is one of 36 patent professionals, and one of only 12 women, recognised in IAM Global Leaders for Australia.

Adele Chadwick, Pearce IP’s Deputy CEO and Head of People says:

“The Pearce IP team consistently ‘punches above its weight’ in client service and in excellence in IP/legal services. But the difference Naomi makes is much more than that. Naomi leads change, takes excellence and client service to the next level, and never stops dreaming up new ways of looking after her leaders and team. Congratulations Naomi – this international ranking is well deserved.”

We congratulate Naomi on her continued recognition as a global leader in IP law and strategy.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Shanghai Henlius Announces First US Approved Interchangeable Biosimilar Pertuzumab

Nov 13, 2025

On 13 November 2025, the FDA announced that it has approved Shanghai Henlius’ Poherdy™ (formerly HLX11, pertuzumab-dpzb) as an interchangeable biosimilar to Roche’s Perjeta®, including in combination with trastuzumab. Henlius’ Poherdy™ is the first pertuzumab biosimilar approved in the US.

In August 2025, Roche and its subsidiary Genentech sued Henlius in ongoing proceedings in the US District Court for New Jersey alleging infringement of patents relating to Perjeta®. The proceeding also names as a defendant Henlius’ licence partner, Organon. Henlius and Organon struck a licensing deal in June 2022 giving Organon exclusive global commercialisation rights to Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.

A day before the FDA announced approval of Poherdy™, Sandoz and EirGenix entered into a global licensing agreement for EirGenix’s pertuzumab biosimilar, giving Sandoz exclusive commercialisation rights worldwide, excluding certain countries in Asia.

FDA Accepts Outlook Therapeutics’ BLA for Ophthalmic Bevacizumab

Nov 13, 2025

On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™ for wet AMD.

The acceptance follows the resubmission of the BLA earlier this month after the company’s Type A meeting with the FDA in September 2025 to address the Complete Response Letter (CRL) issued in August 2025. According to Outlook, the FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 2025 action letter, which results in a 60-day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 31 December 2025.

Outlook had previously resubmitted its BLA to the FDA in February 2025, following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials. A second CRL (August 2025) recommended Outlook submit additional efficacy data to support its application for ONS-5010.

Lytenava™ received marketing authorisation in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025. The Scottish Medicines Consortium also accepted Lytenava™ for use within NHS Scotland in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

Sandoz & EirGenix Global Deal for Biosimilar Pertuzumab

Nov 12, 2025

On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab). Under the agreement, Sandoz will have exclusive worldwide commercial rights to the biosimilar, excluding certain countries in Asia, while EirGenix will be responsible for development, manufacturing and supply.

EG1206A has completed its pharmacokinetic clinical study and last month received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.

Sandoz and EirGenix previously signed a global commercialisation agreement for EG12014, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab), which was approved by the European Commission in November 2023 and is currently under review by the FDA.

Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated. Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

Henlius’ MAAs for Biosimilar Denosumab Accepted in UK

Nov 12, 2025

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (Bildyos®; biosimilar to Amgen’s Prolia®) and 120mg (Bilprevda®; biosimilar to Amgen’s Xgeva®).

Just five days earlier, Boan Biotech announced that its MAAs for denosumab biosimilars, BA6101 (60mg, referencing Prolia®) and BA1102 (120mg, referencing Xgeva®), were also accepted by the MHRA.

There are a number of denosumab biosimilars approved in the UK, including: Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025), Accord’s Osvyrti® (June 2025) and Biocon’s Evfraxy® and Vevzuo® (July 2025).

The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.

Pearce IP BioBlast® for the week ending 7 November 2025

Nov 11, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 7 November 2025 are set out below:

Aflibercept

10 November 2025 | UK | SPC Waiver Win for Alvotech – UK Court Rejects Regeneron/Bayer Injunction Against Alvotech and its CMO
On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the… Read more here.

Bevacizumab

3 November 2025 | US | Outlook Therapeutics Resubmits Ophthalmic Bevacizumab BLA to FDA
On 3 November 2025, Outlook Therapeutics announced that it has re-submitted its Biologics Licence Application (BLA) to the US FDA for its ophthalmic formulation… Read more here.

Denosumab

7 November 2025 | UK | Boan Biotech’s MAAs for Biosimilar Denosumab Accepted in UK

On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing… Read more here.

6 November 2025 | US | Amgen Commences 2 Further BPCIA Denosumab Litigations – Against Alvotech/Dr Reddy’s & Amneal/mAbxience
On 6 November 2025, Amgen filed two separate BPCIA litigation suits in the US District Court for the District of New Jersey, against each of Dr Reddy’s/Alvotech… Read more here.

Golimumab

6 November 2025 | UK | Alvotech/Advanz’s Golimumab UK Approved
On 6 November 2025, Alvotech and Advanz Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved… Read more here.

2 November 2025 | US | FDA Issues CRL for Alvotech’s Biosimilar Golimumab
On 2 November 2025, Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics Licence Application (BLA) for… Read more here.

Nivolumab

4 November 2025 | First Patient Enrolled in Phase I/III Clinical Trials for Xbrane/Intas’ Nivolumab Biosimilar
On 4 November 2025, Xbrane Biopharma announced that the first patient has been enrolled in the clinical trial of Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab)… Read more here.

Olaparib

7 November 2025 | US | Zydus Receives Tentative Approval from FDA for Olaparib Tablets

On 7 November 2025, Medical Dialogues reported that Zydus Lifesciences has received tentative approval from the FDA for olaparib tablets, 100 mg and 150 mg… Read more here.

Ranibizumab, Brolucizumab

20 October 2025 | KR | Santen Pharmaceuticals Inks South Korea Deal with Novartis for Lucentis® and Beovu®
On 20 October 2025, Santen Pharmaceutical announced that Santen Korea has entered into a promotion and distribution agreement in South Korea with Novartis… Read more here.

Ustekinumab

6 November 2025 | EU | Samsung Bioepis and J&J Settle Dispute Over EU Biosimilar Ustekinumab
On 6 November 2025, Samsung Bioepis announced that it has signed a settlement and licence agreement with Johnson & Johnson (J&J) in relation to the European… Read more here.

6 November 2025 | US | Hikma Launches Biosimilar Ustekinumab in the US
On 6 November 2025, Hikma Pharmaceuticals announced its US launch of Starjemza™, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). This is the first biosimilar… Read more here.

BioPharma Deals

4 November | FR | Sandoz Acquires Continuous Manufacturing Company Just-Evotec for USD 350M
On 4 November 2025, Sandoz and Evotec SE announced they have signed an agreement for Sandoz’s acquisition of 100% of Just-Evotec Biologics EU SAS… Read more here.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

Biosimilars Deals 2021

Adalimumab, Omalizumab, Ustekinumab

Aflibercept

Denosumab

Golimumab

Infliximab

Omalizumab

Pembrolizumab

Ranibizumab

Trastuzumab deruxtecan

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

About Pearce IP

Bevacizumab

Denosumab

Denosumab, Insulin Glargine

Guselkumab

Natalizumab

Ocrelizumab

Pembrolizumab

Pertuzumab

Secukinumab

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

About Pearce IP

Aflibercept

Bevacizumab

Denosumab

Golimumab

Nivolumab

Olaparib

Ranibizumab, Brolucizumab

Ustekinumab

BioPharma Deals

About Pearce IP

Naomi Pearce

Chantal Savage

Nathan Kan

Product specific reports based on extracts from our BioBlast® database

Biosimilars Deals

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

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