The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products: Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius…
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 March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study (“TROIKA”) for HD201, a biosimilar to HERCEPTIN (trastuzumab). The results of the TROIKA study were published in JAMA Oncology on March 3, 2022. In the double-blind trial, researchers…
Alvotech and Cipla Medpro, a wholly owned subsidiary of Cipla Limited, recently announced an exclusive partnership “to bring key biosimilars to patients in markets such as South Africa.” The biosimilars portfolio will include two oncology drugs and three drugs for treating autoimmune diseases. The press release reports that under the…
Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody. PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which…
On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®. Prestige’s HD201 is in Phase-3 clinical development for the treatment of patients with HER2-overexpressing breast cancer. According to the press release, under the agreement, Cipla will…