On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories Ltd., Ascend Laboratories, LLC, and Enzene Biosciences Ltd. (“Alkem”) related to Alkem’s submission to the FDA of a Biologic…
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…
Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in three dosage strengths and is indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults. ITP is a…
Enzene Biosciences Ltd., located in Pune, India, has announced that it has obtained marketing authorization from the Drug Controller General of India (DCGI) for its first biosimilar product in India. Enzene’s teriparatide biosimilar, indicated for the treatment of osteoporosis, will be marketed through Enzene’s holding company Alkem Laboratories, Ltd.