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Biocon Biologics gains USFDA approval for two osteoporosis drugs in the US

Synopsis:


Biocon Biologics received USFDA approval for two osteoporosis drugs designed to treat bone loss. Osteoporosis impacts nearly 54 million people in the US. The move strengthens Biocon Biologics’ biosimilar pipeline and expands patient access to affordable treatment options.


Source:
Biocon Ltd. Press Release (NSE Exchange Filings) | Published on Sept 18, 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.

Biocon Biologics news today

As quoted in the press release from Biocon Biologics and its NSE filings, the company announced it has received USFDA approval for two biosimilar drugs to treat osteoporosis and bone loss. The approvals will allow Biocon Biologics to provide cost-effective treatment options in the American market, where osteoporosis affects millions of patients each year.

Key takeaways

  • Biocon Biologics gained USFDA approval for two osteoporosis drugs.

  • Osteoporosis affects 54 million people in the US.

  • The approvals expand the company’s biosimilar portfolio.

  • These drugs aim to reduce fracture risks and bone deterioration.

  • Biocon Biologics share price reflected investor response to the approval.

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BIOCON LIMITED.

Trade

363.959.60 (2.70 %)

Updated - 18 September 2025
364.00day high
DAY HIGH
358.00day low
DAY LOW
1529452
VOLUME (BSE)

Osteoporosis and treatment considerations

Osteoporosis affects the bones and diminishes bone mass and density, which increases the likelihood of fractures. Osteoporosis affects males and females, but women who are post-menopausal are especially at risk. Almost two million fractures each year in the US are due to the condition. Biocon Biologics will enter a therapeutic area with significant unmet need with the launch of its biosimilars for osteoporosis, catering specifically to patients with an intention to find a lower-cost alternative to the branded products currently on the market.

Importance of USFDA approval

USFDA approval is a key milestone for any biosimilar manufacturer, as it demonstrates the safety and efficacy of the products. For Biocon Biologics, the green light further builds its credibility in regulated markets, and advances its organisational structure in the US. Additionally, the USFDA approved biosimilars do expand the biosimilar portfolio beyond diabetes/oncology to musculoskeletal care.

Market opportunity and economic implications

The global market for osteoporosis drugs is expected to reach more than USD 15 billion by 2030, with the largest share in the United States. Biocon Biologics has entered this market with biosimilars to gain value from patients and healthcare providers looking for lower-cost alternative solutions. For patients, the drugs should improve adherence because they are lower-cost treatment alternatives, thus enhancing overall health.

Response to Biocon Biologics share price

On 17 September 2025, at 15:30 PM IST, Biocon Biologics' share price on the NSE stood at ₹302.45. The stock subsequently displayed increased trading activity. Investors interpreted this event as a positive directional movement in Biocon's long-term strategy to further build its biosimilar portfolio and enhance global presence. The approvals are aligned with Biocon Biologics’ share price to focus on regulated markets, enhancing its competitive standing in the pharmaceutical sector.

Table: Biocon Biologics USFDA approval snapshot

Feature

Detail

Company

Biocon Biologics

Approval body

US Food and Drug Administration (USFDA)

Drugs approved

Two biosimilars for osteoporosis and bone loss

Market focus

United States

Patient impact

Addresses 54 million osteoporosis patients in the US

Long-term outlook

Biocon Biologics stated that the newly approved drugs will not only improve patient access in the United States but also reinforce its research partnerships globally. The firm intends to expand manufacturing capabilities to meet growing demand and invest in new therapeutic areas. With these developments, Biocon Biologics is advancing its ambition to provide cost-effective biosimilars for complex diseases across regulated and emerging markets.

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