Monday, 27 June, 2022
HomeANI Press ReleasesEnzene Biosciences Ltd. obtains a Marketing Authorization for its Denosumab Biosimilar drug...

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

Text Size:

Enzene Biosciences Ltd

Pune (Maharashtra) [India], August 27 (ANI/PRNewswire): 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 Europe, Australia, 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), 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.”

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/PRNewswire)

This story is auto-generated from a syndicated feed. ThePrint holds no responsibility for its content.

Subscribe to our channels on YouTube & Telegram

Why news media is in crisis & How you can fix it

India needs free, fair, non-hyphenated and questioning journalism even more as it faces multiple crises.

But the news media is in a crisis of its own. There have been brutal layoffs and pay-cuts. The best of journalism is shrinking, yielding to crude prime-time spectacle.

ThePrint has the finest young reporters, columnists and editors working for it. Sustaining journalism of this quality needs smart and thinking people like you to pay for it. Whether you live in India or overseas, you can do it here.

Support Our Journalism

Most Popular