Read our latest updates & insights

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).  The only issue cited in the CRL relates to unresolved inspection findings at Catalent, the manufactu...

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 inadequat...

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 w...

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.  The permanent injunction follo...

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 biosimil...

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 act...

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 ...

On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.  The CRL follows the December 2024 resubmission of the BLA after the FDA issued a first CRL in April 2024 i...