Zydus Lifesciences Launches Semaglutide, Aflibercept Biosimilar; USFDA Clears Ahmedabad Plant

Zydus Lifesciences plans to launch Semaglutide Injection under the brand names SEMAGLYN, MASHEMA and ALTERME, upon Semaglutide patent expiry in India. The Drug Controller General of India (DCGI) had earlier provided approval for manufacturing and marketing Semaglutide injection for the treatment of Type 2 Diabetes Mellitus and Obesity.

Zydus' Semaglutide offering will include a drug-delivery system developed in India. Unlike treatments that require patients to purchase multiple single-dose pens as they titrate their dosage, Zydus plans to introduce an adjustable single-pen device. The device allows patients to select and administer varying dose strengths from a single unit, with the aim of improving patient adherence, enhancing convenience and reducing the overall cost of therapy. Zydus has exclusive rights to this device, which will be able to deliver all strengths approved for Type 2 Diabetes Mellitus and Obesity. The pen will also be reusable.

As per the International Diabetes Federation, there are 8.9 crore adults with diabetes in India, representing 10.5 per cent of the total adult population. India is witnessing a rise in obesity across age groups. In adults, the prevalence increased by 91 per cent among women (from 12.6 per cent to 24.0 per cent) and 146 per cent among men (from 9.3 per cent to 22.9 per cent).

In a significant product milestone, Zydus Lifesciences announced the launch of ANYRA, India's first indigenously developed biosimilar of Aflibercept 2 mg. The company has entered into an agreement with Regeneron Pharmaceuticals, Inc. and Bayer AG in relation to the product's commercialisation and development.

ANYRA has been introduced for the treatment of several serious retinal disorders. It is indicated for patients suffering from neovascular (wet) age-related macular degeneration (AMD), visual impairment caused by macular oedema following retinal vein occlusion (both branch RVO and central RVO), diabetic macular oedema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularisation (mCNV).

India has over 100 million people living with diabetes, positioning it among the largest diabetic populations globally. An estimated 7 to 8 million individuals are affected by diabetic retinopathy, with many progressing to vision-threatening complications such as DME. Furthermore, wet AMD affects nearly 1.52 million elderly patients, while more than 2 million people suffer from retinal vein occlusions.

The U.S. Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) for injectable medical devices at Zydus' Unit 9 facility located at Zydus Biotech Park, Changodar, Ahmedabad, between February 16 and 19, 2026. The inspection concluded with zero observations, marking a positive regulatory outcome for the company's injectable portfolio and reinforcing its compliance standards in regulated markets.