On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant humanized monoclonal IgG2/4κ antibody that binds to the human c5 complement protein. SOLIRIS® is approved for the treatment of paroxysmal…
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…
Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first biosimilar product KAULIV received a positive recommendation from European Medicines Agency (EMA) for granting market authorization. KAULIV is a biosimilar referencing…
On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for XIMLUCI®. XIMLUCI® is a biosimilar candidate referencing LUCENTIS® (ranibizumab), which is an anti-VEGF (vascular endothelial…
On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the regulation of medicinal products for human use in the European Economic Area, issued a Joint Statement confirming that…
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab. According to the press release, RANIVISIO (ranibizumab) will be the first…
Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®. The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The application is for an intravenous…
On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and its duplicate HERVELOUS, proposed trastuzumab biosimilars of Roche’s HERCEPTIN. TUZNUE and HERVELOUS are intended for the treatment of…
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were invited to solicit scientific advice from regulatory authorities. In the European Economic Area (EEA), biosimilar approval requires applicants to submit…
The Korea Herald has reported that Celltrion Inc., a South Korean biopharmaceutical firm, is seeking approval from the European Medicines Agency (EMA) for the sale of CT-P16, Celltrion’s anticancer biosimilar candidate. CT-P16 references Avastin (Bevacizumab), which is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney…