Alvotech

Alvotech Receives FDA Approval for New SIMLANDI® Manufacturing Process That More Than Doubles Output Per Batch

Alvotech received FDA approval of Process 2.0 for manufacturing the drug substance of SIMLANDI (adalimumab-ryvk), its biosimilar to Humira. The new process more than doubles drug substance output per batch at the company's DSM2 suite in Reykjavik without changing upstream manufacturing scale, with demonstrated comparability in product quality, safety and efficacy. COO Joseph McClellan said the efficiency gain frees capacity for other portfolio products and supports reliable supply to commercial partners as biosimilar demand grows.

•19d ago

REG-Alvotech receives FDA approval for new SIMLANDI® manufacturing process that more than doubles output per batch

Alvotech received FDA approval of a new manufacturing process (Process 2.0) for SIMLANDI, its Humira biosimilar, in its DSM2 suite in Reykjavik. The process more than doubles drug substance output per batch without changing upstream manufacturing scale, with demonstrated comparability in quality, safety and efficacy. Fewer batches for the same output frees capacity for other pipeline products and improves use of existing infrastructure as biosimilar demand grows.

•19d ago

Alvotech and Advanz Pharma announce first known regulatory submission worldwide for proposed biosimilar to Eylea® 8 mg

Alvotech and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg, which they describe as the first known regulatory submission worldwide for this high-dose aflibercept product. The filing was made as a line extension to the existing European marketing authorization for Mynzepli, Alvotech's approved biosimilar to Eylea 2 mg, potentially accelerating the review path. The 8 mg formulation allowed 16-week treatment intervals for certain patients and accounted for roughly 57% of combined global Eylea 2 mg and 8 mg sales by value in Q2 2026, up from about 30% a year earlier. Under the partnership, Alvotech develops and supplies AVT29 while Advanz holds exclusive European commercialization rights, except semi-exclusive rights in Germany and France.

•25d ago

REG-Alvotech and Advanz Pharma announce first known regulatory submission worldwide for proposed biosimilar to Eylea® 8 mg

Alvotech and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept 114.3 mg/mL), which they believe is the first such submission worldwide. The application was filed as a line extension to the European marketing authorization for Mynzepli, Alvotech's approved Eylea 2 mg biosimilar, potentially offering 16-week treatment intervals versus eight weeks for the 2 mg formulation. The high-dose segment is growing fast: the 8 mg formulation accounted for roughly 57% of combined global Eylea 2 mg and 8 mg sales by value in Q2 2026, up from about 30% a year earlier. Under the partnership, Alvotech handles development and commercial supply while Advanz Pharma holds European commercialization rights, exclusive except semi-exclusive rights in Germany and France.

•25d ago

Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply

Alvotech and LOTTE Biologics announced a long-term strategic manufacturing partnership under which LOTTE will produce drug substance for multiple antibody biosimilars at its Syracuse, New York facility for global supply. The Syracuse site offers 40,000 liters of bioreactor capacity, recently completed an unannounced FDA inspection with zero observations, and gives Alvotech a US manufacturing footprint to complement its in-house capabilities. Alvotech CEO Lisa Graver said the expanded network provides capacity to meet demand for the pipeline for the next ten years. Commercial supply remains contingent on technology transfer, manufacturing qualification, and regulatory approvals; no financial terms were disclosed.

•1mo ago

REG-Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply

Alvotech and LOTTE Biologics announced a long-term strategic manufacturing partnership under which LOTTE will produce drug substance for multiple antibody biosimilars at its Syracuse, New York facility for global supply. The Syracuse site has 40,000 liters of bioreactor capacity and recently passed an unannounced FDA inspection with zero observations. CEO Lisa Graver said the expanded network gives Alvotech sufficient capacity to meet pipeline demand for the next ten years. Commercial supply remains contingent on successful technology transfer, manufacturing qualification, and regulatory approvals; no financial terms of the agreement were disclosed.

•1mo ago

FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira®

The FDA approved a BLA supplement enabling Alvotech to manufacture AVT02 (SIMLANDI) drug substance for U.S. supply in a second Reykjavik suite, DSM2. The approval doubles U.S.-supporting drug substance capacity and confirms resolution of FDA inspection-related matters at the Reykjavik site, following a July 2026 inspection closed with a VAI classification. Alvotech expects the FDA to act on pending BLAs (AVT05, AVT06, AVT03, AVT16/AVT80) according to their goal dates; Teva remains the exclusive U.S. commercialization partner for SIMLANDI.

•1mo ago

REG-FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira®

The FDA approved a BLA supplement enabling Alvotech to manufacture AVT02 (SIMLANDI) drug substance for U.S. supply in a second Reykjavik production suite, DSM2. The approval doubles the drug substance capacity available for U.S. commercial supply and further confirms resolution of prior FDA inspection-related matters at the Reykjavik site. Following the July 2026 VAI inspection classification, Alvotech expects FDA action on pending BLAs (AVT03, AVT05, AVT06, AVT16/AVT80) according to their goal dates.

•1mo ago

Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio® to Subcutaneous Presentations

Alvotech announced that the FDA has accepted for review the Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio for subcutaneous administration. This submission expands the company's vedolizumab biosimilar program to include both intravenous (AVT16) and subcutaneous (AVT80) presentations, supported by data from a pivotal pharmacokinetic study. Under a partnership with Teva, Alvotech handles development and manufacturing while Teva manages commercialization; neither product has received regulatory approval yet.

•2mo ago

REG-Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations

Alvotech announced that the FDA has accepted for review the Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio for subcutaneous administration. This milestone expands the company's vedolizumab program alongside AVT16, the intravenous version accepted for review in May, with Teva responsible for commercialization. The submission is supported by data from a pivotal pharmacokinetic study and targets the treatment of ulcerative colitis and Crohn’s disease.

•2mo ago

Alvotech Announces Licensing and Commercialization Agreement with Lotus Pharmaceutical for proposed biosimilars to durvalumab and emicizumab in the U.S. and Selected Asian Markets

Alvotech entered a strategic licensing and commercialization agreement with Lotus Pharmaceutical for its biosimilar candidates AVT34 and AVT87, referencing Imfinzi and Hemlibra respectively. Under the terms, Alvotech retains semi-exclusive rights to commercialize both products in the United States for the first time, while Lotus holds exclusive rights in eight selected Asian markets including South Korea and Taiwan. The agreement offers potential value of up to $150 million to Alvotech through upfront and milestone payments, targeting reference drugs that generated approximately $11.9 billion in combined global sales during 2025.

•2mo ago

REG-Alvotech Announces Licensing and Commercialization Agreement with Lotus Pharmaceutical for proposed biosimilars to durvalumab and emicizumab in the U.S. and Selected Asian Markets

Alvotech announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical covering its biosimilar candidates AVT34 and AVT87 in the U.S. and select Asian markets. The deal carries a potential value of up to $150 million in upfront and milestone payments to Alvotech, plus supply revenues, and marks the first time Alvotech will directly commercialize products in the U.S. The candidates target Imfinzi and Hemlibra, which generated global sales of approximately $6.1 billion and $5.8 billion respectively in 2025.

•2mo ago

REG-Alvotech announces successful closure of FDA inspection of manufacturing facility

The FDA closed its inspection of Alvotech’s Reykjavik manufacturing facility with a classification of Voluntary Action Indicated (VAI), resolving the compliance review without recommending enforcement action. Management confirmed that the actions taken have addressed the agency's observations, removing a key hurdle for the approval of several Biologics License Applications. The company continues to advance its pipeline, highlighted by the resubmission of BLAs for AVT05 and AVT06 and the FDA's acceptance of the BLA for AVT16 in June.

•3mo ago

Alvotech announces successful closure of FDA inspection of manufacturing facility

The FDA closed its inspection of Alvotech’s Reykjavik manufacturing facility, conducted in May 2026, assigning the site a Voluntary Action Indicated (VAI) classification. CEO Lisa Graver stated that the milestone reflects strengthened quality systems and that the company has effectively addressed prior observations, allowing it to advance Biologics License Applications. Alvotech is actively resubmitting BLAs for AVT05 (Simponi biosimilar) and AVT06 (Eylea biosimilar), while its BLA for AVT16 (Entyvio biosimilar) was accepted by the FDA in June 2026.

•3mo ago

REG-Alvotech further strengthens liquidity by securing term loan facility of $75 million

Alvotech has amended its credit agreement to secure a $75 million term loan facility led by GoldenTree Asset Management, maturing on December 31, 2027, with a 12.50% interest rate. This financing follows a recent $165 million equity raise, bringing the company's total access to new capital to $240 million to support its biosimilar pipeline and global product launches. Founder and Chairman Robert Wessman noted that the additional financing provides flexibility to execute strategic priorities and reflects growing confidence from investors.

•4mo ago

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio. AVT16 is developed for intravenous administration and is part of a partnership with Teva Pharmaceutical, which holds commercialization rights. The submission is supported by comprehensive data, including pivotal pharmacokinetic results from a study also supporting the subcutaneous candidate AVT80.

•5mo ago

REG-Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab). AVT16 is being developed for intravenous administration under a partnership with Teva Pharmaceutical, which holds commercialization rights. The submission is supported by comprehensive analytical, pharmacokinetic, and immunogenicity data. This follows positive pivotal PK study results for AVT80 (subcutaneous Entyvio biosimilar) in February 2026. AVT16 is among nine disclosed biosimilar candidates in Alvotech’s pipeline, aiming to expand access to biologic medicines in major therapeutic areas.

•5mo ago

Alvotech announces resubmission of U.S. Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and AVT06, a proposed biosimilar to Eylea®

Alvotech has resubmitted Biologics License Applications (BLAs) to the FDA for AVT05 (biosimilar to Simponi/Simponi Aria) and AVT06 (biosimilar to Eylea). The resubmissions follow the company's response to a Post-Application Action Letter (PAAL) and a routine cGMP inspection of its Reykjavik facility in May 2026. The company expects the FDA to conduct a six-month review of the resubmitted applications, consistent with standard regulatory timelines.

•5mo ago

REG-Alvotech announces resubmission of U.S. Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and AVT06, a proposed biosimilar to Eylea®

Alvotech has resubmitted Biologics License Applications (BLAs) to the FDA for AVT05 (biosimilar to Simponi/Simponi Aria) and AVT06 (biosimilar to Eylea). The resubmissions follow the company's response to a Post-Application Action Letter regarding its Reykjavik manufacturing facility and a routine cGMP inspection completed in May 2026. Alvotech expects the FDA to conduct a six-month review of the resubmitted applications, consistent with standard regulatory timelines.

•5mo ago