Alvotech has moved another step closer to challenging Takeda Pharmaceutical Company’s Entyvio franchise after the United States Food and Drug Administration accepted for review a Biologics License Application for AVT80, the company’s proposed interchangeable biosimilar to subcutaneous vedolizumab. The application covers both a prefilled syringe and autoinjector presentation, giving Alvotech and its United States commercialization partner Teva Pharmaceutical Industries a potential route into maintenance treatment for inflammatory bowel disease patients who use vedolizumab outside an infusion center.
The AVT80 filing complements Alvotech’s separate AVT16 application for an interchangeable intravenous Entyvio biosimilar, which the FDA accepted for review earlier in 2026. Together, the two candidates could eventually allow Alvotech and Teva Pharmaceutical Industries to compete across both major vedolizumab administration formats rather than addressing only the hospital or infusion-center segment. That broader presentation strategy is strategically important as biosimilar competition increasingly depends not only on matching the reference biologic but also on offering patients and physicians comparable convenience across the full product franchise.
AVT80 gives Alvotech a second route into the large vedolizumab inflammatory bowel disease market
Entyvio is a humanized monoclonal antibody used in adults with moderately to severely active ulcerative colitis and Crohn’s disease. Takeda Pharmaceutical Company markets the therapy in both intravenous and subcutaneous formats in the United States, with the subcutaneous version available for maintenance treatment after intravenous induction.
That distinction creates a potentially valuable opening for AVT80. Patients beginning treatment may still receive intravenous vedolizumab, but subcutaneous maintenance allows eligible patients to continue therapy using a prefilled delivery device rather than repeatedly visiting an infusion facility. A biosimilar able to participate in both parts of that treatment pathway could potentially give payers and healthcare systems more flexibility when negotiating access and costs.
Alvotech is developing AVT80 as a prefilled syringe and autoinjector, while AVT16 covers the lyophilized vial used for intravenous administration. The FDA acceptance of both applications means the company now has a regulatory path under review for a matched intravenous and subcutaneous biosimilar portfolio.
The European Medicines Agency has also validated a marketing authorization application covering both AVT16 and AVT80, reinforcing Alvotech’s strategy of pursuing the pair across multiple major pharmaceutical markets rather than treating the subcutaneous product as a United States-only extension.
The opportunity is also notable because Takeda Pharmaceutical Company continues to depend on established gastrointestinal products such as Entyvio as major contributors to its global portfolio. Takeda reported first-quarter fiscal 2026 revenue of ¥1.22 trillion, supported by resilient demand across its core in-line brands, underscoring the scale of the commercial environment in which future vedolizumab biosimilars could compete.
Pivotal pharmacokinetic data support AVT80 interchangeability strategy
The AVT80 application is supported by analytical, pharmacokinetic and immunogenicity evidence designed to demonstrate biosimilarity with reference-product vedolizumab. Alvotech reported in February that a pivotal randomized, double-blind, three-arm pharmacokinetic study comparing AVT80 with Entyvio met all primary endpoints.
According to Alvotech, regulatory advice indicated that the same pivotal clinical study could support the demonstration of clinical similarity for both AVT80 and AVT16. That could provide development efficiency by allowing the company to build a coordinated evidence package around multiple presentations of the same proposed biosimilar molecule.
Alvotech has also requested interchangeable status for AVT80. In the United States, an interchangeable biosimilar that meets the statutory requirements can potentially be substituted for its reference product at the pharmacy without direct intervention from the prescribing physician, subject to individual state laws. That distinction could be especially relevant for a self-administered subcutaneous product dispensed through pharmacy channels.
Interchangeability does not guarantee rapid market adoption, however. Biosimilar uptake can depend on pricing, formulary placement, payer negotiations, pharmacy benefit structures, contracting and physician familiarity. The competitive opportunity therefore extends beyond regulatory approval into execution across reimbursement and distribution. For Alvotech, the subcutaneous presentation may nevertheless improve the strategic value of its vedolizumab program because it reduces the risk of competing only in the intravenous portion of the market while patients and healthcare systems increasingly use more convenient delivery formats.
Teva partnership could accelerate commercialization if both Entyvio biosimilars clear FDA review
Under the companies’ partnership, Alvotech is responsible for developing and manufacturing AVT80, while Teva Pharmaceutical Industries will handle commercialization in the United States. The arrangement reflects a broader biosimilars alliance that combines Alvotech’s development and manufacturing infrastructure with Teva Pharmaceutical Industries’ established United States commercial organization.
The relationship has already produced United States biosimilar launches. Alvotech and Teva Pharmaceutical Industries have previously commercialized SIMLANDI, an interchangeable biosimilar to Humira, and SELARSDI, a biosimilar to Stelara, giving the partnership experience navigating physician adoption, payer contracting and competition against large reference-product franchises.
That experience could become important if AVT16 and AVT80 both secure approval. Rather than introducing a single isolated biosimilar, Teva Pharmaceutical Industries could potentially offer healthcare systems a coordinated vedolizumab portfolio across infusion and self-administered maintenance settings.
The economics of the broader partnership include milestone payments and profit sharing, although specific product-level financial terms remain confidential. Under the original alliance, Alvotech handles development, registration and supply while Teva Pharmaceutical Industries exclusively commercializes partnered products in the United States.
The next-generation pipeline also arrives while Alvotech is trying to restore stronger financial growth following manufacturing-related disruptions. Adjusted first-half 2026 revenue declined 30.8% year over year to $211.9 million, while product and service revenue fell 48.3% to $105.9 million. Management said manufacturing improvements affected output and availability during the period but that production had returned to planned levels by the end of the second quarter.
Alvotech maintained full-year 2026 adjusted revenue guidance of $650 million to $700 million and adjusted EBITDA guidance of $180 million to $220 million. The company ended June with $142.8 million in cash after completing roughly $165 million in equity financing and securing a $75 million term loan facility, providing additional resources as several biosimilar applications move through regulatory review.
Alvotech shares rise as investors price in another FDA-reviewed biosimilar opportunity
Alvotech shares rose roughly 5.4% during August 31 trading and were last quoted around $5.22 after reaching approximately $5.15 earlier in the session, compared with a previous close of $4.95. The move came as investors reacted to the FDA acceptance of AVT80 and followed a series of recent regulatory and licensing developments across the company’s biosimilar pipeline.
The stock remains a higher-risk biosimilar investment because Alvotech is carrying significant debt, operating through a capital-intensive manufacturing model and rebuilding product availability after earlier production constraints. At the same time, its pipeline increasingly contains multiple late-stage candidates capable of expanding revenue if regulatory execution improves.
The company recently received a favorable Voluntary Action Indicated classification following closure of an FDA inspection of its Reykjavik manufacturing facility, while several resubmitted United States applications are targeting regulatory decisions later in 2026. Those developments matter because manufacturing compliance has previously represented a major constraint on Alvotech’s ability to convert its broad pipeline into United States approvals.
AVT80 therefore adds another potentially meaningful asset to a regulatory calendar that is already crowded. The subcutaneous application does not yet establish that Alvotech will successfully enter the Entyvio market, but FDA acceptance confirms that the review process is formally underway while complementing the intravenous AVT16 application.
If both candidates ultimately secure approval and interchangeable designation, Alvotech and Teva Pharmaceutical Industries could approach vedolizumab as a full-franchise biosimilar opportunity covering both infusion-based induction and convenient subcutaneous maintenance. That broader positioning may prove more valuable than competing through a single formulation and could become an important test of whether Alvotech’s increasingly diversified biosimilar pipeline can translate regulatory progress into sustained commercial growth.
