Enzene Biosciences obtains marketing authorization for its first biosimilar molecule in India

Explores potential partnering opportunities

Photo: Raphael Biscaldi on Unsplash

Enzene Biosciences recently announced that it has obtained marketing authorization (MA) from Drug Controller General of India (DCGI) for Teriparatide – bioactive part of human parathyroid hormone (PTH), an anabolic approach to the treatment of Osteoporosis, compared to the anti-resorptive therapies such as bisphosphates and SERMs. According to company sources, the clinical trial conducted for Enzene’s Teriparatide is one of the most comprehensive trial for teriparatide in India, which includes PK (pharmacokinetics), immunogenecity as well as efficacy arm. The company sources also revealed that the approved product will be marketed through their holding company Alkem Laboratories and is also exploring other potential partnering opportunities.

According to Dr Himanshu Gadgil, Whole Time director of Enzene, “We entered the field of biosimilars to bring the highest quality products while also disrupting the barriers for entry. Our Teriparatide will be launched in a fully compliant pen device. We are excited to bring to Indian patients the highest quality standard biosimilars underlining our commitment towards quality and innovation.”

Commenting on the development, Sandeep Singh, managing director, Alkem laboratories, said, “Alkem is one of the leading players in Indian pharmaceutical market. We have always strived to bring to the market high-quality drugs at an affordable price to serve our patients, and investment in biosimilars through our subsidiary Enzene is a step in that direction. I am pleased with the launch of teriparatide and look forward to many more launches from Enzene in the near future.”

Biologics and biosimilars are the next big growth drivers in the global pharmaceutical market, with some of the largest selling molecules in the world belonging to this segment. Alkem, through its subsidiary Enzene, has invested in biosimilars and would look to translate its success in small molecules in biosimilars as well.

Enzene is an innovation-driven biotech company, a subsidiary of Alkem laboratories (which is one of the top five pharmaceutical companies in India), located in Pune, India. Enzene’s focus lies in producing biosimilars, novel biologics, synthetic peptides, and phytopharmaceuticals. Enzene also offers a range of CDMO and CMO services in biologics.


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