Alvotech Announces FDA Completes Facility Inspection
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 11 2026
0mins
Alvotech announces that the FDA has completed a routine cGMP surveillance inspection of the company's manufacturing facility in Reykjavik, Iceland. At the conclusion of the inspection on May 8, the FDA issued a Form 483. The company believes the observations can be addressed quickly and do not raise any substantial issues with the site or its operations. Based on the outcome of the inspection, Alvotech said it is well positioned to resubmit the relevant biologics license applications this quarter, once the final data have been compiled. Alvotech continues to expect FDA approval for the relevant BLAs during 2026.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy ALVO?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on ALVO
Wall Street analysts forecast ALVO stock price to rise
4 Analyst Rating
3 Buy
0 Hold
1 Sell
Moderate Buy
Current: 3.430
Low
5.00
Averages
8.75
High
10.00
Current: 3.430
Low
5.00
Averages
8.75
High
10.00
About ALVO
Alvotech SA is a biotechnology company. The Company is focused on the development and manufacture of biosimilar medicines for patients globally. It is engaged in developing a pipeline of monoclonal antibodies that target a variety of therapeutic areas including inflammatory diseases, oncology, and ophthalmology. The Company’s pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Its products pipeline includes AVT02, AVT04, AVT23, AVT03, AVT05, AVT06, AVT16, and AVT33. Its AVT02 is a monoclonal antibody and a biosimilar to Humira (adalimumab). AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). It has formed a network of strategic commercial partnerships to provide global reach and leverage expertise in markets that include the United States (U.S.), Europe, Japan, China, and other Asian countries and large parts of South America, Africa, and the Middle East.
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.
Alvotech Receives Positive FDA Inspection Outcome
- FDA Inspection Outcome: The U.S. FDA completed a routine cGMP surveillance inspection of Alvotech's Reykjavik facility on May 8, 2026, issuing a Form 483; however, the company stated that the observations can be quickly addressed and do not raise substantial concerns about operations.
- BLA Resubmissions: The positive inspection outcome positions Alvotech to move forward with resubmissions of its Biologics License Applications for AVT03, AVT05, and AVT06, which had previously received Complete Response Letters due to deficiencies linked to the Reykjavik facility.
- Optimistic Market Outlook: Alvotech expects FDA approvals for the pending BLAs later in 2026, targeting major therapeutic areas such as osteoporosis, autoimmune disorders, and eye diseases, indicating strong market potential for these biosimilars.
- Stock Performance: Alvotech's stock has traded between $3.03 and $11.85 over the past year, closing at $3.26, up 1.87%, reflecting market confidence in the company's future developments.
See More
Alvotech Successfully Completes FDA Inspection
- FDA Inspection Outcome: Alvotech's manufacturing facility in Reykjavik, Iceland, completed a routine cGMP inspection by the FDA on May 8, 2026, receiving a Form 483; however, the company believes the observations can be quickly addressed without significant operational impact.
- BLA Resubmission Plans: Following the inspection results, Alvotech is positioned to resubmit the relevant Biologics License Applications (BLA) this quarter, indicating that the company is well-prepared in compiling final data, which is expected to expedite product market entry.
- Strong cGMP Fundamentals: The inspection outcome demonstrates the effectiveness of improvements implemented over the past year, further enhancing Alvotech's competitiveness in the biosimilars market, especially against the backdrop of increasing global demand.
- Future Outlook: Alvotech continues to anticipate FDA approval for the relevant BLAs in 2026, which will solidify the foundation for future product launches and market expansion, positioning the company as a global leader in the biosimilars sector.
See More
Alvotech Q1 Revenue Declines 20.3% Missing Estimates
- Revenue Decline: Alvotech reported Q1 revenue of $105.9 million, reflecting a 20.3% year-over-year decline, which missed market expectations by $34.95 million, indicating significant competitive pressures.
- Adjusted EBITDA: The company achieved an adjusted EBITDA of $24.4 million, which, while positive, suggests challenges in profitability as it shows a decline compared to the previous year, potentially impacting investor confidence.
- Stable Gross Margin: Despite the revenue drop, Alvotech maintained a gross margin of 57%, indicating effective cost control; however, the ongoing revenue decline may threaten future profitability.
- Uncertain Market Outlook: With revenue falling short of expectations, Alvotech faces increased market pressure, prompting investors to closely monitor the company's strategic adjustments and market responses to assess its long-term growth potential.
See More
Alvotech General Counsel Resigns, New CEO Takes Over
- Executive Change: Alvotech's General Counsel Tanya Zharov has announced her resignation after six years, during which she played a crucial role in preparing the company for public listings across multiple markets, highlighting potential challenges in executive stability.
- Leadership Transition: New CEO Lisa Graver will take over Zharov's role, marking a significant shift in the company's leadership that could impact strategic direction and market confidence.
- Continued Support: Although Zharov is stepping down, she will continue to support the company for several months to ensure a smooth transition, indicating the company's commitment to stability and continuity during executive changes.
- Global Market Expansion: Alvotech has launched five biosimilars in various markets and is developing nine additional candidates, demonstrating its potential for growth and competitive positioning in the global biopharmaceutical sector.
See More
Alvotech Files Annual Report for 2025 with SEC
- Annual Report Submission: Alvotech filed its 2025 Annual Report with the SEC on March 30, 2026, providing detailed financial information aimed at enhancing transparency and boosting investor confidence.
- Biosimilar Market Focus: The company specializes in the development and manufacturing of biosimilars, with five products already approved and marketed globally, demonstrating its strong competitive position in the biopharmaceutical sector.
- Development Pipeline: Alvotech has nine disclosed biosimilar candidates in development targeting autoimmune disorders, eye diseases, osteoporosis, respiratory diseases, and cancer, showcasing its extensive market potential.
- Global Strategic Partnerships: The company has formed a network of strategic commercial partnerships across the U.S., Europe, Japan, China, and other Asian countries, aiming to leverage local expertise to expand its market reach and enhance global operational capabilities.
See More
Alvotech Releases Annual Report for 2025
- Annual Report Release: Alvotech published its 2025 Annual Report on March 30, 2026, which is available in the investor relations section of the company’s website, marking an enhancement in transparency and information disclosure.
- Biosimilar Market Positioning: The company has already approved and marketed five biosimilars in multiple global markets, including Humira® and Stelara®, demonstrating its competitiveness and market recognition in the biopharmaceutical sector.
- Pipeline Expansion: Alvotech currently has nine biosimilar candidates under development targeting autoimmune disorders, eye diseases, osteoporosis, respiratory diseases, and cancer, indicating its commitment to addressing diverse patient needs.
- Global Strategic Partnerships: The establishment of a strategic commercial partnership network across the U.S., Europe, Japan, China, and other Asian countries enhances Alvotech's influence in global markets and leverages local expertise.
See More
Alvotech Receives Positive FDA Inspection Outcome
- FDA Inspection Outcome: The U.S. FDA completed a routine cGMP surveillance inspection of Alvotech's Reykjavik facility on May 8, 2026, issuing a Form 483; however, the company stated that the observations can be quickly addressed and do not raise substantial concerns about operations.
- BLA Resubmissions: The positive inspection outcome positions Alvotech to move forward with resubmissions of its Biologics License Applications for AVT03, AVT05, and AVT06, which had previously received Complete Response Letters due to deficiencies linked to the Reykjavik facility.
- Optimistic Market Outlook: Alvotech expects FDA approvals for the pending BLAs later in 2026, targeting major therapeutic areas such as osteoporosis, autoimmune disorders, and eye diseases, indicating strong market potential for these biosimilars.
- Stock Performance: Alvotech's stock has traded between $3.03 and $11.85 over the past year, closing at $3.26, up 1.87%, reflecting market confidence in the company's future developments.
See More
Alvotech Successfully Completes FDA Inspection
- FDA Inspection Outcome: Alvotech's manufacturing facility in Reykjavik, Iceland, completed a routine cGMP inspection by the FDA on May 8, 2026, receiving a Form 483; however, the company believes the observations can be quickly addressed without significant operational impact.
- BLA Resubmission Plans: Following the inspection results, Alvotech is positioned to resubmit the relevant Biologics License Applications (BLA) this quarter, indicating that the company is well-prepared in compiling final data, which is expected to expedite product market entry.
- Strong cGMP Fundamentals: The inspection outcome demonstrates the effectiveness of improvements implemented over the past year, further enhancing Alvotech's competitiveness in the biosimilars market, especially against the backdrop of increasing global demand.
- Future Outlook: Alvotech continues to anticipate FDA approval for the relevant BLAs in 2026, which will solidify the foundation for future product launches and market expansion, positioning the company as a global leader in the biosimilars sector.
See More
Alvotech Q1 Revenue Declines 20.3% Missing Estimates
- Revenue Decline: Alvotech reported Q1 revenue of $105.9 million, reflecting a 20.3% year-over-year decline, which missed market expectations by $34.95 million, indicating significant competitive pressures.
- Adjusted EBITDA: The company achieved an adjusted EBITDA of $24.4 million, which, while positive, suggests challenges in profitability as it shows a decline compared to the previous year, potentially impacting investor confidence.
- Stable Gross Margin: Despite the revenue drop, Alvotech maintained a gross margin of 57%, indicating effective cost control; however, the ongoing revenue decline may threaten future profitability.
- Uncertain Market Outlook: With revenue falling short of expectations, Alvotech faces increased market pressure, prompting investors to closely monitor the company's strategic adjustments and market responses to assess its long-term growth potential.
See More
Alvotech General Counsel Resigns, New CEO Takes Over
- Executive Change: Alvotech's General Counsel Tanya Zharov has announced her resignation after six years, during which she played a crucial role in preparing the company for public listings across multiple markets, highlighting potential challenges in executive stability.
- Leadership Transition: New CEO Lisa Graver will take over Zharov's role, marking a significant shift in the company's leadership that could impact strategic direction and market confidence.
- Continued Support: Although Zharov is stepping down, she will continue to support the company for several months to ensure a smooth transition, indicating the company's commitment to stability and continuity during executive changes.
- Global Market Expansion: Alvotech has launched five biosimilars in various markets and is developing nine additional candidates, demonstrating its potential for growth and competitive positioning in the global biopharmaceutical sector.
See More
Alvotech Files Annual Report for 2025 with SEC
- Annual Report Submission: Alvotech filed its 2025 Annual Report with the SEC on March 30, 2026, providing detailed financial information aimed at enhancing transparency and boosting investor confidence.
- Biosimilar Market Focus: The company specializes in the development and manufacturing of biosimilars, with five products already approved and marketed globally, demonstrating its strong competitive position in the biopharmaceutical sector.
- Development Pipeline: Alvotech has nine disclosed biosimilar candidates in development targeting autoimmune disorders, eye diseases, osteoporosis, respiratory diseases, and cancer, showcasing its extensive market potential.
- Global Strategic Partnerships: The company has formed a network of strategic commercial partnerships across the U.S., Europe, Japan, China, and other Asian countries, aiming to leverage local expertise to expand its market reach and enhance global operational capabilities.
See More
Alvotech Releases Annual Report for 2025
- Annual Report Release: Alvotech published its 2025 Annual Report on March 30, 2026, which is available in the investor relations section of the company’s website, marking an enhancement in transparency and information disclosure.
- Biosimilar Market Positioning: The company has already approved and marketed five biosimilars in multiple global markets, including Humira® and Stelara®, demonstrating its competitiveness and market recognition in the biopharmaceutical sector.
- Pipeline Expansion: Alvotech currently has nine biosimilar candidates under development targeting autoimmune disorders, eye diseases, osteoporosis, respiratory diseases, and cancer, indicating its commitment to addressing diverse patient needs.
- Global Strategic Partnerships: The establishment of a strategic commercial partnership network across the U.S., Europe, Japan, China, and other Asian countries enhances Alvotech's influence in global markets and leverages local expertise.
See More
