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Biocon Biologics Signs Global Settlement for Biosimilar Aflibercept

Infosys Completes Share Buyback, Extinguishes 10 Crore Shares

Synopsis:


Biocon Biologics signed a settlement and licence agreement with Regeneron and Bayer to commercialise biosimilar Aflibercept worldwide. The agreement follows an earlier settlement for the United States and Canada and enables global commercialisation of Yesafili®.


Source:
 Biocon Limited Press Release (BSE Exchange Filings) | Published on Dec 13, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release from Biocon Limited and its news (NSE Exchange Filings), Biocon Biologics Ltd shared details of a new settlement and licence agreement with stock exchanges. The disclosure was filed with BSE and NSE on December 13, 2025.

Biocon Biologics is a subsidiary of Biocon Limited. The agreement was signed with Regeneron and Bayer. It covers Europe and other global regions. This settlement follows an earlier agreement that covered the United States and Canada.

The company stated that all pending legal cases linked to biosimilar Aflibercept were dismissed after the agreement. The filing also states that other terms of the settlement are confidential.

BIOCON LIMITED.

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390.654.29 (1.11 %)

Updated - 15 December 2025
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Key Takeaways

  • Biocon Biologics signed a settlement and licence agreement for biosimilar Aflibercept.

  • The agreement covers Europe and other global markets.

  • A previous settlement already covered the United States and Canada.

  • The agreement was signed with Regeneron and Bayer.

  • Regulatory approvals for the product were already received.

Scope of the Settlement Agreement

The settlement allows Biocon Biologics to commercialise Yesafili®. Yesafili is a biosimilar Aflibercept with a strength of 40 mg/ml. The agreement applies to countries worldwide.

Yesafili is a vascular endothelial growth factor inhibitor. It is used to treat eye-related conditions. These conditions affect vision.

The listed uses include wet age-related macular degeneration. They also include diabetic macular oedema. Other uses relate to retinal vein occlusion and myopic choroidal neovascularisation.

The company also confirmed that Yesafili received approvals from the European Commission. Approval was also granted by the Medicines & Healthcare products Regulatory Agency in the UK.

Commercialisation and Regulatory Timeline

The exchange filing states that the agreement allows the launch of Yesafili in the United Kingdom in January 2026. Launch in other settled countries is scheduled for March 2026. In some cases, the launch may take place earlier.

The filing also repeats earlier disclosures for North America. Market entry for the United States was secured in April 2025. The disclosed entry period is the second half of calendar year 2026.

Yesafili was launched in Canada earlier in 2025. Market entry for Canada was secured in March 2024.

Also read: BEL Wins Orders Worth ₹776 Crore for Defence and Strategic Electronics Systems in India

Settlement Coverage Summary

Particulars

Details

Product

Yesafili® (Biosimilar Aflibercept 40 mg/ml)

Agreement Type

Settlement And Licence

Partners

Regeneron And Bayer

Geographic Coverage

Worldwide

Regulatory Authorities

EC And MHRA

Disclosure Source

BSE And NSE Filings

Biocon Share Price Update

As per exchange data on 12 December 2025 at 15:30 PM IST, Biocon Limited's share price was ₹385.35. The stock closed higher by ₹3.60. This reflects a gain of 0.94%. The previous closing price was ₹381.75. During the session, the stock opened at ₹382.70. It reached a high of ₹388.75. It touched a low of ₹382.50. The volume-weighted average price was ₹386.46.

 

Published Date : 15 Dec 2025

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