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ALVO Stock Gains 19% on FDA Resubmission of Biosimilar BLAs
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Key Takeaways
Alvotech resubmitted FDA applications for biosimilars AVT05 and AVT06 after corrective actions.
ALVO addressed manufacturing issues cited by the FDA and enhanced quality systems.
AVT05 and AVT06 already hold approvals across Europe, the UK, Japan and other regions.
Shares of Alvotech (ALVO - Free Report) , a biotechnology company specializing in the development and manufacturing of biosimilar medicines, jumped 19% after the company announced the resubmission of biologics license applications (BLAs) to the FDA for two key biosimilar candidates, AVT05 and AVT06.
AVT05 is a proposed biosimilar to Simponi and Simponi Aria (golimumab), therapies used to treat a range of chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. AVT06 is a proposed biosimilar to Eylea (aflibercept), a leading retinal disease treatment indicated for retinal diseases such as wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion.
Alvotech is developing AVT05 and AVT06 in its partnership with Teva Pharmaceutical Industries (TEVA - Free Report) . Per the agreement, Alvotech is responsible for product development and manufacturing, while TEVA holds commercialization rights.
Year to date, shares of Alvotech have lost 27.1% compared with the industry’s 1.1% decline.
Image Source: Zacks Investment Research
ALVO’s Regulatory Progress for AVT05 & AVT06
The original BLA for AVT05 was accepted by the FDA in January 2025, while the BLA for AVT06 was accepted in February 2025. However, in November, Alvotech received a Complete Response Letter (CRL) for AVT05 due to manufacturing deficiencies identified during the FDA's July 2025 inspection of the company's Reykjavik manufacturing facility. Notably, the FDA did not raise concerns regarding the biosimilar itself. The company had not mentioned any specific date for the issuance of the CRL for AVT06.
The latest resubmissions follow Alvotech's response to the FDA's Post-Application Action Letter and corrective measures implemented after a routine current Good Manufacturing Practice inspection completed in May 2026. The company has since strengthened its manufacturing processes and quality systems and expects the FDA to complete its review of the resubmitted applications within six months.
AVT05 and AVT06 have already received approvals in multiple international markets, including Europe, the U.K., Japan and other regions, validating their regulatory and commercial potential. In the United States, AVT05 is being developed as a biosimilar to Simponi in its subcutaneous formulation and to Simponi Aria in an intravenous formulation.
ALVO’s Zacks Rank & Stocks to Consider
Alvotech currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 4.3% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, loss per share estimates for Immunocore’s 2026 have improved from 88 cents to earnings per share of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
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ALVO Stock Gains 19% on FDA Resubmission of Biosimilar BLAs
Key Takeaways
Shares of Alvotech (ALVO - Free Report) , a biotechnology company specializing in the development and manufacturing of biosimilar medicines, jumped 19% after the company announced the resubmission of biologics license applications (BLAs) to the FDA for two key biosimilar candidates, AVT05 and AVT06.
AVT05 is a proposed biosimilar to Simponi and Simponi Aria (golimumab), therapies used to treat a range of chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. AVT06 is a proposed biosimilar to Eylea (aflibercept), a leading retinal disease treatment indicated for retinal diseases such as wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion.
Alvotech is developing AVT05 and AVT06 in its partnership with Teva Pharmaceutical Industries (TEVA - Free Report) . Per the agreement, Alvotech is responsible for product development and manufacturing, while TEVA holds commercialization rights.
Year to date, shares of Alvotech have lost 27.1% compared with the industry’s 1.1% decline.
Image Source: Zacks Investment Research
ALVO’s Regulatory Progress for AVT05 & AVT06
The original BLA for AVT05 was accepted by the FDA in January 2025, while the BLA for AVT06 was accepted in February 2025. However, in November, Alvotech received a Complete Response Letter (CRL) for AVT05 due to manufacturing deficiencies identified during the FDA's July 2025 inspection of the company's Reykjavik manufacturing facility. Notably, the FDA did not raise concerns regarding the biosimilar itself. The company had not mentioned any specific date for the issuance of the CRL for AVT06.
The latest resubmissions follow Alvotech's response to the FDA's Post-Application Action Letter and corrective measures implemented after a routine current Good Manufacturing Practice inspection completed in May 2026. The company has since strengthened its manufacturing processes and quality systems and expects the FDA to complete its review of the resubmitted applications within six months.
AVT05 and AVT06 have already received approvals in multiple international markets, including Europe, the U.K., Japan and other regions, validating their regulatory and commercial potential. In the United States, AVT05 is being developed as a biosimilar to Simponi in its subcutaneous formulation and to Simponi Aria in an intravenous formulation.
ALVO’s Zacks Rank & Stocks to Consider
Alvotech currently carries a Zacks Rank #3 (Hold).
Two better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share estimates for Indivior Pharmaceuticals remained unchanged at $4.05 for 2026 and $4.27 for 2027. INDV shares have risen 4.3% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 30 days, loss per share estimates for Immunocore’s 2026 have improved from 88 cents to earnings per share of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 17.3% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.