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Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

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Recent BioBlast® Updates

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.

Formycon Announces Dupilumab Biosimilar in Development

Nov 17, 2025

On 17 November 2025, Formycon revealed that it is developing FYB208, a biosimilar candidate to Sanofi/Regeneron’s Dupixent® (dupilumab).  According to Formycon, preclinical development is completed and it is working on…

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. 

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…

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®).

Russian Pembrolizumab Biosimilar Approved in Vietnam

Nov 11, 2025

On 11 November 2025, Viet Nam News, reported that the Vietnam Ministry of Health has granted marketing authorisation for Pembroria™, biosimilar to MSD’s Keytruda® (pembrolizumab), in Vietnam for a three-year period. 

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