Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the period 22 December 2024 to 17 January 2025 are set out below:
Adalimumab
1 January 2025 | AU | Sandoz’s High Concentration Adalimumab Biosimilar PBS-Listed
On 1 January 2025, Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in a 40 mg/0.4 mL injection, 2 x 0.4 mL pen formulation for the same indications as Humira®… Read more here.
Aflibercept
13 January 2025 | EU | IS | Teva and Klinge/Formycon Partner to Commercialise Aflibercept Biosimilar in EU and Israel
Amivantamab
30 December 2024 | EU | New Indication Alert: J&J Receives EU Approval for Amivantamab Combination Treatment for NSCLC
On 30 December 2024, Johnson & Johnson (J&J) announced that the European Commission has approved a Type II variation extension of indication for its Rybrevant® (amivantamab) as … Read more here.
Bevacizumab
16 January 2025 | US | Outlook Therapeutics Plans BLA Resubmission to FDA for Ophthalmic Bevacizumab Following Positive Clinical Trial Results
On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD. The results are said to… Read more here.
21 December 2024 | UK | Approval Alert: CuraTeQ’s Biosimilar Bevacizumab Receives UK Approval
On 21 December 2024, CuraTeQ Biologics announced that it has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva™,… Read more here.
Daratumumab
27 December 2024 | US | FDA Approves Global Phase 3 Trial for Celltrion’s Daratumumab Biosimilar
On 27 December 2024, Celltrion announced that the US FDA has approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of CT-P44, biosimilar to Johnson & Johnson’s… Read more here.
Datopotamab deruxtecan
18 January 2025 | JP | US | EU | Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer
On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults… Read more here.
Denosumab
10 January 2025 | NZ | New Zealand’s Pharmac Widens Access to Amgen’s Denosumab
On 10 January 2025, New Zealand’s Pharmac announced that it will be expanding access to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.
24 December 2024 | GlycoNex Announces Licensing Deal for Denosumab Biosimilar
On 24 December 2024, GlycoNex announced that it has entered into a licensing agreement with an undisclosed partner for SPD8 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. Under the… Read more here.
Eculizumab
10 January 2025 | US | Samsung Bioepis and Teva Strike Partnership for US Commercialisation of Eculizumab Biosimilar
On 10 January 2025, Samsung Bioepis and Teva announced they have entered into a licence, development and commercialisation agreement for Epysqli® (eculizumab-aagh), biosimilar to… Read more here.
20 December 2024 | EU | UPC Eculizumab Litigation Update: Preliminary Injunctions Against Samsung Bioepis and Amgen Denied by Court of Appeal
On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of biosimilars to Alexion’s Soliris® (eculizumab) in … Read more here.
Enfortumab vedotin
8 January 2025 | CN | New Indication Alert: Astellas’ Padcev™ Combination Therapy Approved in China for Urothelial Cancer
On 8 January 2025, Astellas Pharma announced that China’s National Medical Products Administration (NMPA) has approved its Padcev™ (enfortumab vedotin) in combination with Merck’s … Read more here.
Epcoritamab
6 January 2025 | AU | Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in Australia
On 6 January 2025, the Therapeutic Goods Administration (TGA) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate solution and 48mg/0.8mL solution for injection vial… Read more here.
Lecanemab
14 January 2025 | US | US FDA Accepts Eisai/Biogen’s BLA for Leqembi® Subcutaneous Maintenance Dosing
On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly… Read more here.
Liraglutide
15 January 2025 | Lexaria Bioscience to Commence Human Study of Oral Liraglutide Formulation
On 15 January 2025, Lexaria Bioscience announced that it has received independent ethics board approval to begin its first-ever human study of oral liraglutide, formulated from the DehydraTECH… Read more here.
2 January 2025 | US | Novo Nordisk Submits Citizen Petition Seeking to Block Compounded Victoza®
On 2 January 2025, the FDA published a Citizen Petition filed by Novo Nordisk seeking to exclude its type 2 diabetes liraglutide injection Victoza® (liraglutide) from a proposed list of drugs eligible for… Read more here.
26 December 2024 | US | Hikma’s Generic Version of Novo Nordisk’s Diabetes Drug Victoza® Approved and Launched in US
On 26 December 2024, Hikma Pharmaceuticals announced that it has received FDA approval for, and launched, its generic version of Novo Nordisk’s Victoza® (liraglutide) in the US in a 6mg/mL dosage… Read more here.
24 December 2024 | EU | Biocon Receives EU Approval for Generic Liraglutide
On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union. The approval … Read more here.
Mepolizumab
3 January 2025 | CN | New Indication Alert: GSK’s Nucala® Approved in China for CRSwNP
On 3 January 2025, GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala® (mepolizumab) as an add-on therapy with intranasal corticosteroids for the … Read more here.
Mirikuzumab
15 January 2025 | US | New Indication Alert: FDA Approves Eli Lilly’s Omvoh® for Crohn’s Disease
On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This follows FDA approval of Omvoh® for ulcerative… Read more here.
Nipocalimab
9 January 2025 | US | J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis
On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) … Read more here.
Nivolumab
27 December 2024 | US | BMS’ Subcutaneous Nivolumab FDA-Approved
On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of … Read more here.
23 December 2024 | EU | New Indication Alert: BMS’ Opdivo® and Yervoy® Combination Therapy Receives New EU Approval
On 23 December 2024, following the November 2024 recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission… Read more here.
Ocrelizumab
13 January 2025 | Amgen’s Ocrelizumab Biosimilar in Phase 3 Trials
At the JP Morgan Annual Healthcare conference on 13 January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) in Phase 3 trials. The Phase 3 study … Read more here.
Pembrolizumab
14 January 2025 | MSD Planning 2025 SC Pembrolizumab Launch
At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck (known as MSD outside the US and Canada) announced that it is expecting to “file, have approval, and launch… Read more here.
Posdinemab
8 January 2025 | US | J&J’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease
On 8 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted Fast Track designation to its posdinemab. Posdinemab is a phosphorylated tau-directed monoclonal antibody … Read more here.
Semaglutide
17 January 2025 | Novo Nordisk’s High Dose Semaglutide Demonstrates 20.7% Weight Loss in Ph 3b Trial
On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly… Read more here.
Tislelizumab
6 January 2025 | US | AU | New Indication Alert: BeiGene’s Tevimbra® Receives New Indication Approvals in Australia and the US
On 6 January 2025, the Australian Therapeutic Goods Administration (TGA) approved an indication expansion for BeiGene’s Tevimbra® (tislelizumab) in combination with platinum-based… Read more here.
Ustekinumab
16 January 2025 | TR | Bio-Thera and World Medicine Partner to Commercialise Ustekinumab Biosimilar in Turkey
On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s … Read more here.
15 January 2025 | UK | CA | Formycon/Fresenius’ Biosimilar Ustekinumab Approved in UK and Canada
On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s… Read more here.
7 January 2025 | JP | Biocon’s Biosimilar Ustekinumab Approved in Japan
On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s… Read more here.
24 December 2024 | SA | Bio-Thera & Tabuk Pharmaceuticals Seal Saudi Arabian Licensing Deal for Ustekinumab Biosimilar
On 24 December 2024, Bio-Thera Solutions announced that it has entered an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company in relation to the commercialisation of BAT2206 (ustekinumab)… Read more here.
Zolbetuximab
9 January 2025 | CA | CN | Astellas’ Vyloy® Combo Approved in Canada and China for Gastric and GEJ Cancer
On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy… Read more here.
Company News
16 January 2025 | US | Samsung Bioepis Publishes Eighth Biosimilar Market Report
On 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report. The report has been released every quarter since April 2023 and details average sales price information … Read more here.
13 January 2025 | MENA | ASIA | LATAM | Henlius and Abbott Partner on Biosimilar Commercialisation in Emerging Markets
On 13 January 2025, Shanghai Henlius announced that it has entered a product licence and supply agreement with Abbott under which Abbott is granted exclusive or semi-exclusive rights to the… 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.