Enzene Biosciences receives Marketing Authorization for Teriparatide

February 15, 20210

Enzene Biosciences announced that they have obtained marketing authorization in India for their first biosimilar, Teriparatide. Enzene Biosciences is a subsidiary of Alkem Laboratories, leading to the developing of biosimilars, phytopharmaceuticals, and regenerative medicine. Before Enzene Biosciences, Alkem had introduced a teriparatide biosimilar, GEMTIDE, an anabolic injection for treating patients with severe osteoporosis. Teriparatide is identical to a bioactive part of the human parathyroid hormone, and this product will be marketed through Alkem laboratories.  

Intending to provide the Indian markets with high-quality drugs at reasonable prices, Enzene Biosciences developed Teriparatide as a fully compliant pen device. Enzene’s Teriparatide will now compete with the many other teriparatide biosimilars present in the market by Intas, Zydus, Glenmark, Alkem, Virchow, Emcure, among many others along with Eli Lilly’s Forsteo, the original product that the FDA approved in November 2002 and by the EMA in June 2003. The patents on Forteo expired in the US and Europe in August 2009 that has led to the development of many biosimilars referencing Forteo (Fortseo), beginning with Intas pharmaceuticals’ Terifrac Injection that was approved in India in November 2010, followed by Cadila Pharmaceutical product approved in August of 2012 along with NuPTH, another teriparatide biosimilar in 2020.  NuPTH, as announced by Cadila Pharmaceuticals, is a Forteo biosimilar and will be available to the patients as a cost-effective, easy to use, pre-filled disposable pen.  

 The number of Teriparatide biosimilars indicates a large osteoporosis market segment and an increasing focus on women’s health, the target segment for this product. This approval for Enzene brings optimism to its development capabilities and moves towards translating its pipeline molecules’ success. 

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