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Apr 25, 2025
On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars…
Apr 24, 2025
On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and…
Apr 24, 2025
On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD for patent infringement in the US District Court for the District of New Jersey…
Apr 24, 2025
On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars…
Apr 22, 2025
The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a…
Apr 18, 2025
On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU)…
Apr 18, 2025
On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept…
Apr 16, 2025
On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars…On 16 April 2025, EmblemHealth, a US nonprofit health insurer, filed a class action complaint in the US District Court for the District of Massachusetts alleging that AstraZeneca subsidiary, Alexion…
Apr 16, 2025
On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and…
Apr 15, 2025
On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing…
Apr 15, 2025
On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, dismissing pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™…
Apr 14, 2025
On 14 April 2025, Sandoz announced that it has filed an antitrust lawsuit against Amgen in the US District Court of for the Eastern District of Virginia in relation to etanercept. Sandoz’s complaint…
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