Shots:The US FDA has approved Camcevi ETM (leuprolide mesylate, 21mg, Q3M LAI) for the treatment of advanced prostate cancer; Application is under the EMA’s reviewApproval was based on P-III trial assessing Camcevi ETM in 144 advanced prostate cancer pts, which showed superior efficacy, with 97.9% pts achieving the 1EPCamcevi (Q6M LAI) is…
Shots: Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…
Shots:FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…
Shots:Intas has acquired Coherus’ Udenyca business (incl. prefilled syringe, autoinjector & on-body injector), a biosimilar version of Amgen’s Neulasta (pegfilgrastim) via 2024 asset purchase agreement; Accord BioPharma (Intas’ US specialty division) will handle Udenyca’s US businessAs per the deal, Coherus received $483.4M upfront in cash, incl. $118.4M for Udenyca inventory, with an additional…
Shots: The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025 The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
Shots: The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025 The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…
Shots :The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara Accord BioPharma…
Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…

