Read our latest updates & insights

On 20 August 2025, Korea Biomedical Review reported that Sam Chun Dang’s biosimilar of Regeneron/Bayer’s 2mg Eylea® (aflibercept) received European marketing authorisation in both vial and pre-filled syringe forms (PFS).

According to the report, Sam Chun Dang (SCD) c...

On 19 August 2025, BMS announced that Health Canada has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high or mismat...

On 19 August 2025, CSPC Pharmaceutical announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection, biosimilar to Sanofi/Regeneron’s Dupixent®.  According to CSPC, the product, wh...

On 18 August 2025, MedImpact Holdings Inc. announced that, from 1 January 2026, Teva subsidiary Anda’s unbranded ustekinumab-aekn (biosimilar to J&J/Janssen’s Stelara®) will be available for direct purchase from MedImpact’s preferred partner, Birdi, Inc., by any license...

On 18 August 2025, Accord BioPharma announced the US commercial launch of Imuldosa® PFS, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  The Imuldosa® syringes are to be supplied at the lowest wholesaler acquisition cost (WAC) price among branded ustekinumab biosim...

On 14 August 2025, Genentech and Hoffman-La Roche filed BPCIA litigation in the US District Court for the District of New Jersey alleging infringement of 24 US patents relating to their Perjeta® branded pertuzumab cancer treatment.  The allegations relate to Shanghai Henliu...

Paraguay-headquartered Bioéticos, which is part of Laboratorio Productos Eticos C.E.I.S.A (a member of Savone Holding and part of Insud Pharma) claims to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  According to a ba...

On 13 August 2025, Shanghai Henlius and Hong Kong-headquartered EssexBio announced that China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted for review their New Drug Application (NDA) for HLX04-0, an ophthalmic preparation ...