Biocon Share Price Sees Surge Following USFDA Approval for Cancer Biosimilar

Market Performance

Biocon's share price increased 5.5% during intra-day trading on April 11, 2025. Following a positive regulatory update, the stock reached a session high of ₹322.25. Despite the current uptrend, the stock continues to trade over 20% lower than its 52-week high of ₹404.60 recorded in January 2025. The stock had previously bottomed out at ₹260 in April 2024.

Over the last 12 months, Biocon has recorded an overall growth of approximately 10%. The price movement in recent months has been marked by fluctuations: an 8% decline in April so far, a 13% gain in March, a 16.5% fall in February, and a minor 1% decrease in January.

Regulatory Development

Biocon Biologics, a subsidiary of Biocon, has received regulatory clearance from the U.S. Food and Drug Administration (USFDA) for JOBEVNE, a biosimilar to Bevacizumab intended for intravenous use. The approval marks Biocon's seventh biosimilar approved in the U.S., representing a key step in strengthening its oncology portfolio.

JOBEVNE is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), as a result it hinders the formation of blood vessels that feed tumors. This mechanism reduces or halts tumor growth.

Company Overview

Biocon Biologics already markets other oncology biosimilars in the U.S., including OGIVRI (Trastuzumab-dust) and FULPHILA (Pegfilgrastim-IMDb). The company also commercializes its Bevacizumab biosimilar under ABEVMY in Europe and Canada, with approvals granted in February 2021 and November 2021, respectively.

The U.S. market for Bevacizumab-based treatments recorded sales close to USD 2 billion in 2023. With the addition of JOBEVNE, Biocon aims to strengthen its position in this therapeutic segment.

Biocon's board has approved a plan to raise ₹600 crore by issuing commercial papers via private placement to support future growth. The objective is to enhance liquidity and fund the company's strategic initiatives.

In another development, Biocon Pharma—a different arm of the group—secured USFDA approval on March 24 for its Abbreviated New Drug Application related to Norepinephrine Bitartrate Injection USP. This medication is used to manage acute hypotension in adults, and its approval highlights Biocon's diversified presence across therapeutic areas.

Summary

Biocon's recent regulatory approvals from the USFDA, including the clearance for JOBEVNE, signify continued progress in the biosimilar space. These developments, along with its existing product line and international market presence, reflect the company's expanding role in oncology and other treatment segments. The positive market reaction highlights growing confidence in Biocon's regulatory and operational capabilities.