Enzene Biosciences Ltd. Obtains A Marketing Authorization For Its Denosumab Biosimilar Drug In India

Pune /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), 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."

About Enzene Biosciences Ltd.
Enzene is an innovation-driven biotech company, a subsidiary of Alkem Laboratories Ltd. (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 biologics CDMO and CMO services.

(*as per the latest IQVIA data of MAT July 2021)

For more information on Enzene Biosciences Ltd., please visit www.enzene.com

For more information on Alkem Laboratories Ltd., please visit www.alkemlabs.com