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What is the story about?
Pharma stocks are in focus on Monday, December 15, after two firms received form 483 from the US drug regulator, while another signed a settlement agreement.
Dr Reddy's Laboratories Ltd., Aurobindo Pharma Ltd. received five and three observations in their respective form 483s, while Biocon Ltd.'s subsidiary inked a settlement and licensing agreement with Regeneron and Bayer for Aflibercept for Europe and the rest of the world.
The US Food and Drug Administration (USFDA)issued Form 483 with five observations to the pharma company after its inspection at its formulations facility in Srikakulam, Andhra Pradesh.
The inspection was a combination of good manufacturing practices (GMP) review and a pre-approval inspection (PAI). It was conducted from December 4 to December 12, 2025.
Dr Reddy's said it would address the observations within the stipulated timeframe.
The company's stock ended the previous trade session 0.5% up at ₹1,280 apiece. It has declined 6.5% this year, so far.
The USFDA also issued Form 483 with three observations to Aurobindo Pharma after completing its inspection of the company's Unit-V, an active pharmaceutical ingredient (API) manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Pvt. Ltd., in Telangana.
The company said the observations were procedural in nature. It added that it would give its response to the regulator in the stipulated timeline.
The US drug regulator had conducted the inspection from December 1 to December 12, 2025.
Aurobindo Pharma said the development does not impact the operations at the facility.
Shares of Aurobindo Pharma ended the previous session nearly 2% up at ₹1,195.1 apiece. The stock has declined 11.7% this year, so far.
Biocon on Saturday said its subsidiary Biocon Biologics has signed a settlement and licence agreement to commercialise the biosimilar Aflibercept globally.
The new agreement with Regeneron and Bayer for the biosimilar in Europe and the rest of the world, follows an earlier settlement covering the US and Canada.
This clears the way for Biocon Biologics to commercialise Yesafili, a biosimilar Aflibercept (40mg/ml), in all countries across the globe.
Yesafili is a vascular endothelial growth factor inhibitor used to treat multiple ophthalmology conditions, the company said.
Biocon Biologics, Regeneron and Bayer inked the agreement to dismiss all pending litigation, it added. The agreement now enables the company to launch Yesafili in the UK in January 2026 and in the remaining settled countries in March 2026 or earlier in certain circumstances.
The other terms of the settlement are confidential, Biocon said.
Biocon shares ended the previous trade session 0.9% up at ₹385.35 apiece. The stock has declined 8.5% in the past month.
Also Read: Hindustan Zinc share price rally draws Jefferies' attention, says 'Buy' for 18% upside
Dr Reddy's Laboratories Ltd., Aurobindo Pharma Ltd. received five and three observations in their respective form 483s, while Biocon Ltd.'s subsidiary inked a settlement and licensing agreement with Regeneron and Bayer for Aflibercept for Europe and the rest of the world.
Dr Reddy's Laboratories
The US Food and Drug Administration (USFDA)issued Form 483 with five observations to the pharma company after its inspection at its formulations facility in Srikakulam, Andhra Pradesh.
The inspection was a combination of good manufacturing practices (GMP) review and a pre-approval inspection (PAI). It was conducted from December 4 to December 12, 2025.
Dr Reddy's said it would address the observations within the stipulated timeframe.
The company's stock ended the previous trade session 0.5% up at ₹1,280 apiece. It has declined 6.5% this year, so far.
Aurobindo Pharma
The USFDA also issued Form 483 with three observations to Aurobindo Pharma after completing its inspection of the company's Unit-V, an active pharmaceutical ingredient (API) manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Pvt. Ltd., in Telangana.
The company said the observations were procedural in nature. It added that it would give its response to the regulator in the stipulated timeline.
The US drug regulator had conducted the inspection from December 1 to December 12, 2025.
Aurobindo Pharma said the development does not impact the operations at the facility.
Shares of Aurobindo Pharma ended the previous session nearly 2% up at ₹1,195.1 apiece. The stock has declined 11.7% this year, so far.
Biocon
Biocon on Saturday said its subsidiary Biocon Biologics has signed a settlement and licence agreement to commercialise the biosimilar Aflibercept globally.
The new agreement with Regeneron and Bayer for the biosimilar in Europe and the rest of the world, follows an earlier settlement covering the US and Canada.
This clears the way for Biocon Biologics to commercialise Yesafili, a biosimilar Aflibercept (40mg/ml), in all countries across the globe.
Yesafili is a vascular endothelial growth factor inhibitor used to treat multiple ophthalmology conditions, the company said.
Biocon Biologics, Regeneron and Bayer inked the agreement to dismiss all pending litigation, it added. The agreement now enables the company to launch Yesafili in the UK in January 2026 and in the remaining settled countries in March 2026 or earlier in certain circumstances.
The other terms of the settlement are confidential, Biocon said.
Biocon shares ended the previous trade session 0.9% up at ₹385.35 apiece. The stock has declined 8.5% in the past month.
Also Read: Hindustan Zinc share price rally draws Jefferies' attention, says 'Buy' for 18% upside
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