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 forms of multiple sclerosis (MS). TYRUKO® is also indicated for inducing and maintaining clinical response and remission in adult patients…
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 denosumab biosimilar. According to Amgen, PROLIA is “prescribed to treat patients with…
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 ankylosing spondylitis (AS) and rheumatoid arthritis (RA). This is Enzene’s fourth biosimilar launch in the last eighteen months. In…