Zydus Lifesciences in focus after USFDA clears Ahmedabad plant, Aflibercept biosimilar launch

Shares of Zydus Lifesciences are likely to remain in focus during Friday’s trading session after the company announced two key developments, the successful closure of a USFDA inspection at its Ahmedabad injectables facility and the launch of India’s first indigenously developed biosimilar of Aflibercept.

USFDA inspection clears with nil observations

The company informed exchanges that the U.S. Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) for injectable medical devices at its Unit 9 facility located at Zydus Biotech Park, Changodar, Ahmedabad, between February 16 and 19, 2026.


Importantly, 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.

Launch of ANYRA, India’s first indigenous Aflibercept biosimilar

In a significant product milestone, Zydus Lifesciences Ltd. announced the launch of ANYRA, India’s first indigenously developed biosimilar of Aflibercept 2 mg. The company has also 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). With this launch, Zydus strengthens its presence in the ophthalmology segment while advancing its strategy to improve access to high-quality, affordable biologic therapies in India.

The opportunity landscape remains substantial. 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, underscoring a significant unmet need in the country’s ophthalmic care space.

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Stock performance

On Thursday, shares of Zydus Lifesciences settled 0.85% lower at Rs 902.40 on the NSE.

With regulatory clearance and a significant biosimilar launch, the stock could see heightened investor attention in the upcoming session.

On the technical front, data from Trendlyne shows that Zydus Lifesciences has a 14-day Relative Strength Index (RSI) of 50.1. Typically, an RSI reading below 30 indicates that a stock is oversold, while a level above 70 suggests it is overbought.

In terms of moving averages, the stock is exhibiting a bearish trend, as it is currently trading below six out of its eight simple moving averages (SMAs), indicating subdued momentum in the near term.

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