Enzene Biosciences Ltd. obtains a Marketing Authorization for its Denosumab Biosimilar drug in India

29 August 2021 | Sunday | News

Enzene Biosciences Ltd. "Enzene" announces a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its third biosimilar drug 'Denosumab', indicated for the treatment of osteoporosis in adults.

Osteoporosis is a commonly occurring condition associated with advanced age, and is frequently caused by oestrogen decline in post-menopausal women. It can lead to severe clinical consequences, such as back pain and bone fractures (particularly in the spine and hips). Denosumab acts as an anti-resorptive therapy by inhibiting the activity of the cytokine RANKL (which is associated with increased osteoclast activity that results in higher bone turnover than bone formation), thereby enabling the restoration of positive bone balance in osteoporosis patients.

According to Dr. Himanshu Gadgil, Enzene's Whole Time Director, "Enzene has been at the forefront of the development of intensified biomanufacturing process platforms for monoclonal antibodies and we are excited to have obtained approval for our first Biosimilar mAb. We are seeking to broaden this platform through strategic global partnerships for product licensing and contract manufacturing." The company also stated that they have signed licensing and supply agreements in EuropeAustralia, the UK, and South Korea and are looking to further expand the product label in various geographies across the world.

Noting that this is Enzene's third biosimilar authorization (Enzene's Teriparatide and Romiplostim were approved by the DCGI earlier this year), Mr. Sandeep Singh, Managing Director, Alkem Laboratories Ltd. said, "Alkem is happy to announce another major step towards providing access to medicines treating chronic ailments, with the launch of Denosumab biosimilar. We are committed to invest in the further development of our Denosumab biosimilar, and build on our exceptional strength in global clinical trials to obtain FDA approval and subsequent commercialisation in the US market through our subsidiary Ascend Laboratories LLC."

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