Read our latest updates & insights

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 colitis in October 2023.

In August 2...

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-processing of conventional injected liraglutide (Novo Nordisk’s Saxenda®).

On 15 January 2025, Gedeon Richter and Mochida Pharmaceutical Co. announced positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19, biosimilar to Roche’s Actemra® (tocilizumab).  The Phase 1 study evaluated the pharmacokinetic equivalence between RGB-...

On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®.  The petition challenges claims 1-17, 19-42, 44-50 as invalid for lack of novelty...

At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, MSD announced that it is expecting to “file, have approval, and launch [its] subcutaneous pembrolizumab in 2025”.

The announcement follows positive topline results obtained in November 2024 f...

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 maintenance dosing for the treatment of Alzheimer’s disease in patients with M...

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 commercialisation of four biosimilars and one innovative biologic.  The commercialis...

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 (NCT06700343), which begins enrolment this month in the US, is aimed at demonstrating pharmacokin...

On 13 January 2025, Teva Pharmaceuticals announced that it has entered into a strategic collaboration agreement with Klinge Biopharma and Formycon for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Europe (excluding Ital...