No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Oct 29, 2025
The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stobocolo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia® and Xgeva®, respectively, for all approved indications, effective as of 29 October 2025.
Oct 29, 2025
On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (biosimilar to Genentech’s Lucentis® (ranibizumab)) and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)).
Oct 29, 2025
On 29 October 2025, the FDA announced proposed measures to make it faster and less costly to develop biosimilars, by simplifying biosimilarity studies, reducing unnecessary clinical trials and facilitating pharmacy level substitution.
Oct 27, 2025
On 27 October 2025, China Medical Holdings Limited announced that its subsidiary, CMS Vision International Management Limited, has entered into a distribution agreement with Novartis Pharma Services AG for Lucentis® (ranibizumab) and Beovu® (brolucizumab).
Oct 27, 2025
On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg).
Oct 24, 2025
On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Oct 24, 2025
On 24 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved Novo Nordisk’s Alhemo® (concizumab) for the prevention or reduction in the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with haemophilia A or B with inhibitors.
Oct 24, 2025
On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries.
Oct 23, 2025
On 23 October 2025, Samsung Bioepis published its eleventh US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.
Oct 23, 2025
On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.
Oct 21, 2025
On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™, biosimilar to Genentech’s Lucentis® (ranibizumab), making the product the first ranibizumab biosimilar approved in Africa.
Oct 21, 2025
On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.