Amneal Receives FDA Approval for Two Biosimilars
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 23 2025
0mins
Source: NASDAQ.COM
- Biosimilar Approval: Amneal Pharmaceuticals announced FDA approval for its biosimilars Boncresa and Oziltus, referencing Prolia and XGEVA, with plans to commercialize six biosimilars by 2027, significantly enhancing the company's competitive edge in the biopharmaceutical market.
- Market Potential: According to IQVIA, annual U.S. sales for Amgen's Prolia and XGEVA were approximately $5.3 billion for the 12 months ending October 2025, indicating substantial commercial opportunities in the biosimilar market.
- Strategic Partnership: Amneal's collaboration with Spain-based mAbxience, responsible for the development and manufacturing of Denosumab while Amneal holds exclusive U.S. commercialization rights, will further solidify its market position.
- Long-term Growth Outlook: Amneal's co-CEOs stated that biosimilars represent the next wave of affordable medicines in the U.S., and the addition of two denosumab biosimilars will strengthen their position in this rapidly growing category, serving as a key driver for sustainable growth.
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Analyst Views on AMRX
Wall Street analysts forecast AMRX stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for AMRX is 13.75 USD with a low forecast of 12.00 USD and a high forecast of 15.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 14.110
Low
12.00
Averages
13.75
High
15.00
Current: 14.110
Low
12.00
Averages
13.75
High
15.00
About AMRX
Amneal Pharmaceuticals, Inc. is a global pharmaceutical company, which develops, manufactures, markets and distributes a portfolio of essential medicines. Its Affordable Medicines segment includes a portfolio of over 280 product families covering a range of dosage forms and delivery systems, including both immediate and extended-release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmic, films, transdermal patches and topicals. Its Specialty segment is engaged in the development, promotion, sale and distribution of branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease and endocrine disorders. Its AvKARE segment provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, predominantly focused on the U.S. Department of Defense and the U.S. Department of Veterans Affairs.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Amneal Pharmaceuticals Settles Majority of Opioid Claims for Up to $267M
- Settlement Agreement Effective: Amneal Pharmaceuticals announced that its opioid settlement agreement will take effect on Thursday, allowing claimants to receive up to $267 million in cash and overdose treatments, indicating proactive legal risk management by the company.
- Cash Payment Structure: Under the Nationwide Opioids Settlement Agreement, participating states and jurisdictions can receive $88.5 million in cash and up to $177.4 million worth of naloxone nasal spray, demonstrating the company's commitment to addressing public health crises.
- Cash Payment Cap: The agreement allows litigants to opt for 25% of the naloxone spray's value as cash payments during the last four years of the decade-long term, with a maximum of $44.4 million, which may alleviate cash flow pressures for the company.
- Potential Total Cash Payments: Amneal anticipates total cash payments could reach $132.9 million under the agreement, reflecting the company's financial commitment to resolving legal disputes and its implications for future operations.
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