On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab…...more
Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39...more
On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar Tyruko® (natalizumab-sztn), developed by Polpharma Biologics. Tyruko® injection is the first and only FDA-approved biosimilar for relapsing...more
On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a...more
As reported by HealthCareRadius in India, on February 23, 2023, Enzene Biosciences, a subsidiary of Alkem Laboratories, announced commencement of commercial supplies of its biosimilar adalimumab (ENZ-129) in India to treat...more