Biosimilars Deals 2021 Archives

Pearce IP BioBlast® for the week ending 28 March 2025

Apr 1, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 28 March 2025 are set out below:

Denosumab

26 March 2025 | US | Approval Alert: FDA Approves Denosumab Biosimilars for Fourth Sponsor

On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s… Read more here.

Denosumab, Ustekinumab

27 March 2025 | EU | Positive Opinions for Accord’s Denosumab and Celltrion’s Ustekinumab Biosimilars in EU

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars… Read more here.

Golimumab, Ustekinumab

26 March 2025 | ASIA | Bio-Thera and Dr Reddy’s Enter SE Asia Commercialisation Agreement for Golimumab and Ustekinumab Biosimilars

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s… Read more here.

Mepolizumab

24 March 2025 | EU | EMA Accepts GSK’s Mepolizumab Indication Expansion Application for COPD

On 24 March 2025, GSK announced that the European Medicines Agency (EMA) has accepted for review its application to expand the use of Nucala® (mepolizumab) as an add-on maintenance… Read more here.

Ocrelizumab

27 March 2025 | AU | Roche’s High Dose Ocrelizumab Approved in Australia

On 27 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Roche’s high dose Ocrevus® (ocrelizumab) in a 920mg/23ml solution for injection. This adds to the 300mg/10ml formulation… Read more here.

Omalizumab

26 March 2025 | UK | Alvotech/Kashiv/Advanz’s Omalizumab Biosimilar MAA Accepted in UK

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23… Read more here.

Pembrolizumab

27 March 2025 | US | FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025

On 27 March 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab… Read more here.

Tocilizumab

27 March 2025 | EU | EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s… Read more here.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

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

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

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

AZ’s Imfinzi® (durvalumab) US-Approved for Muscle Invasive Bladder Cancer

Mar 28, 2025

On 28 March 2025, the US FDA approved AstraZeneca’s Imfinzi® (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

AstraZeneca’s sBLA for Imfinzi® for the MIBC indication was granted priority review by the FDA in December 2024. In February 2025, Australia’s TGA accepted for review an indication expansion of Imfinzi® for MIBC.

EMA Accepts Henlius/Organon’s MAA for Biosimilar Pertuzumab

Mar 28, 2025

On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

Henlius/Organon have previously had applications for HLX11 accepted by the US FDA (February 2025) and China’s Center for Drug Evaluation of the National Medical Products Administration (December 2024).

In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

Roche’s High Dose Ocrelizumab Approved in Australia

Mar 27, 2025

On 27 March 2025, Australia’s Therapeutic Goods Administration (TGA) approved Roche’s high dose Ocrevus® (ocrelizumab) in a 920mg/23ml solution for injection. This adds to the 300mg/10ml formulation of Ocrevus® approved by the TGA in July 2017. Both formulations are indicated for the treatment of patients with primary progressive and relapsing forms of multiple sclerosis.

In January 2025, at the JP Morgan Annual Healthcare conference, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials. Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).

New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Nephrotic Syndrome

Mar 27, 2025

On 27 March 2025, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for “frequently relapsing or steroid-dependent nephrotic syndrome” in childhood (IV injection, 100mg and 500mg) that has not yet become intractable.

Rituxan® was approved in Japan in November 2024 for chronic idiopathic thrombocytopenic purpura (ITP) in children. Prior to this, Rituxan® had only been approved in Japan for chronic ITP in adults.

Rituximab was one of the first mAbs to become “biosimilar”. Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).

CHMP Recommends Indication Expansions for BMS’ Opdivo®, Janssen’s Tremfya® and Beigene’s Tevimbra®

Mar 27, 2025

At its March meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions for seven indication expansions, including to:

BMS’ Opdivo® (nivolumab) in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo® as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression at or higher than 1%.
Janssen’s Tremfya® (guselkumab) for treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment; and
Beigene’s Tevimbra® (tislelizumab) in combination with etoposide and platinum chemotherapy, for first-line treatment of adults with extensive-stage SCLC.

The CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Subcutaneous Opdivo® has previously been approved in the US for most but not all previously approved adult, solid tumour indications.

EMA Accepts Gedeon Richter’s Application for Biosimilar Tocilizumab

Mar 27, 2025

On 27 March 2025, Gedeon Richter announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab). This follows Gedeon’s announcement of positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19 in January 2025, both of which met their primary endpoints.

RGB-19 was co-developed by Mochida and Gedeon Richter. Mochida will file marketing authorisation applications for RGB-19 in Japan, while Richter will do so in major global markets outside Japan.

In February 2025, Celltrion’s Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025

Mar 27, 2025

On 27 March 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab plus berahyaluronidase alfa), with indications across all previously approved solid tumour indications for Keytruda®. The FDA has set a PDUFA, or target action, date of 23 September 2025.

Reuters has reported that Merck/MSD intends to launch SC pembrolizumab on 1 October 2025. This aligns with Merck/MSD’s previously expressed expectations of a 2025 launch for the subcutaneous product.

According to Merck/MSD, the European Medicines Agency (EMA) has also validated an extension application to introduce a new pharmaceutical form and new route of administration for Keytruda®.

Positive Opinions for Accord’s Denosumab and Celltrion’s Ustekinumab Biosimilars in EU

Mar 27, 2025

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars.

Accord Healthcare’s Jubereq® and Osvyrti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab) respectively, have received recommendations for the same indications as the reference products.

In addition, the CHMP has recommended Celltrion’s Qoyvolma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024). The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).

Alvotech/Kashiv/Advanz’s Omalizumab Biosimilar MAA Accepted in UK

Mar 26, 2025

On 26 March 2025, Alvotech, Kashiv Biosciences and Advanz Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted its application for marketing authorisation (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

In February 2023, Alvotech and Advanz Pharma entered into an exclusive agreement in relation to the commercialisation of AVT23, under which Alvotech was responsible for development and manufacture, while Advanz Pharma handles registration and commercialisation. In October 2023, Alvotech entered into an exclusive licensing agreement with Kashiv in relation to AVT23. Under that agreement, Alvotech has an exclusive licence to commercialise AVT23 in the EU, the UK, Australia, Canada, and New Zealand, while Kashiv is responsible for the development and manufacturing of the biosimilar.

Celltrion’s omalizumab biosimilar, Omlyclo® (CT-P39), was the first to be approved in the UK in July 2024. In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK patent for an omalizumab formulation (EP (UK) 3 805 248), finding it was valid and infringed by Celltrion.

Bio-Thera and Dr Reddy’s Enter SE Asia Commercialisation Agreement for Golimumab and Ustekinumab Biosimilars

Mar 26, 2025

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively.

Under the agreement, Bio-Thera will be responsible for developing, manufacturing and supplying BAT2206 and BAT2506 and Dr Reddy’s will commercialise the products in certain Southeast Asian countries, including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam. Dr Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia. The SE Asia deal follows agreements that Bio-Thera entered with Intas/Accord in February 2025 and STADA in May 2024 for the commercialisation of golimumab (BAT2506) in the US and Europe, respectively.

In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206 (ustekinumab), under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries. Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024. A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

Approval Alert: FDA Approves Denosumab Biosimilars for Fourth Sponsor

Mar 26, 2025

On 26 March 2025, Fresenius Kabi announced that the US FDA approved its Biologics Licence Application (BLA) for Conexxence® and Bomyntra® (denosumab-bhnt), biosimilars to Amgen’s Prolia® and Xgeva® respectively, for all reference indications. Fresenius is the fourth sponsor to have denosumab biosimilars approved in the US.

Under the terms of a settlement between Fresenius Kabi and Amgen, resulting in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen in October 2024, Fresenius Kabi may launch its denosumab biosimilars in the US in “mid-2025”.

Fresenius Kabi has also confirmed that the global settlement permits European launch of its denosumab biosimilars “later in H2 of 2025”, subject to regulatory approvals.

There are three sponsors with denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024). A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024). Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

New Indication Alert: Sanofi’s Dupixent® Obtains Japanese Approval for COPD

Mar 25, 2025

On 28 March 2025, Sanofi and Regeneron announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorisation for Dupixent® (dupliumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

Dupixent® was approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.

Pearce IP BioBlast® for the week ending 21 March 2025

Mar 25, 2025

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

Certolizumab

20 March 2025 | Alvotech Acquires Xbrane’s Swedish R&D Operations & Biosimilar Peg-Certolizumab

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol). Xbrane will retain … Read more here.

Denosumab

19 March 2025 | KR | Celltrion Launches Biosimilar Denosumab in Korea; Samsung Bioepis Inks Deal with Hanmi Ahead of Korean Denosumab Biosimilar Launch

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28%… Read more here.

18 March 2025 | US | FDA Accepts Alvotech/Dr Reddy’s BLA for Biosimilar Denosumab

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.

Guselkumab

20 March 2025 | US | New Indication Alert: J&J’s Guselkumab FDA Approved for Crohn’s Disease

On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease. According to… Read more here.

Pembrolizumab

19 March 2025 | US | New Indication Alert: FDA Approves MSD’s Keytruda® Combo for HER2 Positive Gastric or GEJ Adenocarcinoma

On 19 March 2025, the US FDA approved Merck/MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment… Read more here.