BAJAJ BROKING
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.
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.
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.
Also read: Titagarh Rail delivers first Diving Support Craft to Navy
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.
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.
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.
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.
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 |
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.
Share this article:
Disclaimer :
The information on this website is provided on "AS IS" basis. Bajaj Broking (BFSL) does not warrant the accuracy of the information given herein, either expressly or impliedly, for any particular purpose and expressly disclaims any warranties of merchantability or suitability for any particular purpose. While BFSL strives to ensure accuracy, it does not guarantee the completeness, reliability, or timeliness of the information. Users are advised to independently verify details and stay updated with any changes.
The information provided on this website is for general informational purposes only and is subject to change without prior notice. BFSL shall not be responsible for any consequences arising from reliance on the information provided herein and shall not be held responsible for all or any actions that may subsequently result in any loss, damage and or liability. Interest rates, fees, and charges etc., are revised from time to time, for the latest details please refer to our Pricing page.
Neither the information, nor any opinion contained in this website constitutes a solicitation or offer by BFSL or its affiliates to buy or sell any securities, futures, options or other financial instruments or provide any investment advice or service.
BFSL is acting as distributor for non-broking products/ services such as IPO, Mutual Fund, Insurance, PMS, and NPS. These are not Exchange Traded Products. For more details on risk factors, terms and conditions please read the sales brochure carefully before investing.
Investments in the securities market are subject to market risk, read all related documents carefully before investing. This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.
For more disclaimer, check here : https://www.bajajbroking.in/disclaimer
Level up your stock market experience: Download the Bajaj Broking App for effortless investing and trading