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On 21 August 2025, Alvotech and Advanz Pharma announced that Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s 2mg Eylea® (aflibercept) has been approved by the European Commission in pre-filled syringe and vial presentations.  Mynzepli® received a positive CHMP opinion in...

On 20 August 2025, Regeneron announced that the FDA has extended its target action dates to Q4/2025 for two Eylea HD® (aflibercept, 8mg) regulatory submissions:

a supplemental BLA (accepted by the FDA for Priority Review in April 2025) seeking approval for the trea...

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...