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Aug 21, 2025
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-
Aug 20, 2025
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:
Aug 20, 2025
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
Aug 19, 2025
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
Aug 19, 2025
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
Aug 18, 2025
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.
Aug 18, 2025
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
Aug 14, 2025
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®
Aug 14, 2025
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
Aug 13, 2025
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
Aug 12, 2025
On 12 August 2025, Celltrion announced that it has been awarded a series of supply contracts in Italy for its autoimmune disease therapies and oncology treatments. Key contracts include additional
Aug 12, 2025
On 12 August 2025, Lupin announced that it has partnered with Sandoz to market and commercialise Lupin’s biosimilar ranibizumab (referencing Genentech’s Lucentis®) across the
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