Amneal Receives FDA Approval for Two Biosimilars
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 23 2025
0mins
Should l Buy AMRX?
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: 14.770
Low
12.00
Averages
13.75
High
15.00
Current: 14.770
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.
See More
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- Fulgent Genetics Rise: Fulgent Genetics, Inc. (FLGT) rose 5.98% to $28.90 in after-hours trading, gaining $1.63, reflecting market optimism regarding its business outlook.
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Amneal Pharmaceuticals (AMRX) Expects to Meet or Exceed Expectations
- Earnings Outlook: Amneal Pharmaceuticals disclosed in a regulatory filing on Tuesday that it expects to meet or exceed market expectations, indicating the company's stable growth potential in the pharmaceutical market.
- Market Confidence: This outlook may bolster investor confidence in Amneal, particularly in the current competitive pharmaceutical landscape, suggesting positive advancements in product development and market strategies.
- Regulatory Compliance: The timely release of earnings expectations demonstrates the company's commitment to transparency and compliance, which can enhance market trust in its governance structure.
- Future Prospects: Amneal's earnings outlook could lay the groundwork for future investment and expansion plans, particularly in new drug development and market penetration, further driving the company's long-term growth.
See More
Amneal Secures FDA Approval for Six Biosimilars by 2027
- Biosimilar Expansion: Amneal, in collaboration with mAbxience, has received FDA approval for Boncresa™ and Oziltus™, with plans to commercialize six biosimilars by 2027, thereby solidifying its position in the rapidly growing biosimilars market.
- Market Potential: According to IQVIA, annual U.S. sales for Prolia® and XGEVA® were approximately $5.3 billion for the 12 months ending October 2025, and Amneal's biosimilars will provide more affordable treatment options, addressing the increasing market demand.
- Strategic Partnership: In this FDA approval, mAbxience is responsible for development and manufacturing while Amneal holds exclusive U.S. commercialization rights, a collaboration that not only enhances both parties' market competitiveness but also strengthens Amneal's innovative capabilities in biopharmaceuticals.
- Long-Term Growth Potential: Amneal's co-CEOs stated that biosimilars represent a significant long-term growth vector within their Affordable Medicines segment, with expectations to drive future revenue growth through an expanded product portfolio.
See More
Amneal Receives FDA Approval for Two Biosimilars
- 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.
See More
Amneal Receives FDA Approval for Six Biosimilars by 2027
- Biosimilar Expansion: Amneal, in partnership with mAbxience, has received FDA approval for Boncresa™ and Oziltus™, with plans to commercialize six biosimilars by 2027, thereby strengthening its position in the rapidly growing biosimilars market.
- Market Potential: According to IQVIA, U.S. annual sales for Prolia® and XGEVA® were approximately $5.3 billion for the 12 months ending October 2025, indicating that Amneal's biosimilars will provide cost-effective treatment options to meet increasing market demand.
- Strategic Collaboration: In this partnership, mAbxience is responsible for development and manufacturing while Amneal holds exclusive U.S. commercialization rights, which will enhance product quality and market responsiveness, thereby boosting competitiveness for both companies.
- Long-term Growth Strategy: Amneal's co-CEOs stated that biosimilars represent a significant long-term growth vector within their Affordable Medicines segment, with expectations to enhance overall company performance through an expanded product portfolio.
See More
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.
See More
Healthcare Stocks Surge in After-Hours Trading
- Acumen Pharmaceuticals Surge: Acumen Pharmaceuticals, Inc. (ABOS) advanced 8.09% in after-hours trading to close at $2.94, adding $0.22, indicating strong investor confidence in its growth prospects.
- Fulgent Genetics Rise: Fulgent Genetics, Inc. (FLGT) rose 5.98% to $28.90 in after-hours trading, gaining $1.63, reflecting market optimism regarding its business outlook.
- Fractyl Health Growth: Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23 after hours, up $0.11, suggesting that its potential in the biotech sector is being recognized by the market.
- Coeptis Therapeutics Increase: Coeptis Therapeutics Holdings, Inc. (COEP) added 4.14% to finish at $13.85, gaining $0.55 in after-hours trading, demonstrating investor support for its strategic direction.
See More
Amneal Pharmaceuticals (AMRX) Expects to Meet or Exceed Expectations
- Earnings Outlook: Amneal Pharmaceuticals disclosed in a regulatory filing on Tuesday that it expects to meet or exceed market expectations, indicating the company's stable growth potential in the pharmaceutical market.
- Market Confidence: This outlook may bolster investor confidence in Amneal, particularly in the current competitive pharmaceutical landscape, suggesting positive advancements in product development and market strategies.
- Regulatory Compliance: The timely release of earnings expectations demonstrates the company's commitment to transparency and compliance, which can enhance market trust in its governance structure.
- Future Prospects: Amneal's earnings outlook could lay the groundwork for future investment and expansion plans, particularly in new drug development and market penetration, further driving the company's long-term growth.
See More
Amneal Secures FDA Approval for Six Biosimilars by 2027
- Biosimilar Expansion: Amneal, in collaboration with mAbxience, has received FDA approval for Boncresa™ and Oziltus™, with plans to commercialize six biosimilars by 2027, thereby solidifying its position in the rapidly growing biosimilars market.
- Market Potential: According to IQVIA, annual U.S. sales for Prolia® and XGEVA® were approximately $5.3 billion for the 12 months ending October 2025, and Amneal's biosimilars will provide more affordable treatment options, addressing the increasing market demand.
- Strategic Partnership: In this FDA approval, mAbxience is responsible for development and manufacturing while Amneal holds exclusive U.S. commercialization rights, a collaboration that not only enhances both parties' market competitiveness but also strengthens Amneal's innovative capabilities in biopharmaceuticals.
- Long-Term Growth Potential: Amneal's co-CEOs stated that biosimilars represent a significant long-term growth vector within their Affordable Medicines segment, with expectations to drive future revenue growth through an expanded product portfolio.
See More
Amneal Receives FDA Approval for Two Biosimilars
- 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.
See More
Amneal Receives FDA Approval for Six Biosimilars by 2027
- Biosimilar Expansion: Amneal, in partnership with mAbxience, has received FDA approval for Boncresa™ and Oziltus™, with plans to commercialize six biosimilars by 2027, thereby strengthening its position in the rapidly growing biosimilars market.
- Market Potential: According to IQVIA, U.S. annual sales for Prolia® and XGEVA® were approximately $5.3 billion for the 12 months ending October 2025, indicating that Amneal's biosimilars will provide cost-effective treatment options to meet increasing market demand.
- Strategic Collaboration: In this partnership, mAbxience is responsible for development and manufacturing while Amneal holds exclusive U.S. commercialization rights, which will enhance product quality and market responsiveness, thereby boosting competitiveness for both companies.
- Long-term Growth Strategy: Amneal's co-CEOs stated that biosimilars represent a significant long-term growth vector within their Affordable Medicines segment, with expectations to enhance overall company performance through an expanded product portfolio.
See More
