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U.S. FDA and EMA have accepted regulatory submissions for AVT02 - Alvotech

19 November 2020
  • Alvotech is developing AVT02 as a proposed biosimilar to HUMIRA® (adalimumab) with high concentration (100mg/mL) dosage forms
  • AVT02 is highly similar to its reference product in terms of structure and function
  • The pharmacokinetic (PK) similarity study for AVT02 (AVT02-GL-101) has met its primary objectives
  • The comparative confirmatory efficacy and safety study for AVT02 (AVT02-GL-301) has met its primary objective

Alvotech today announced that its U.S. subsidiary Alvotech USA Inc. has filed a Biologics License Application (BLA) for AVT02 to the U.S. Food and Drug Administration (FDA), which has been accepted for review.  The FDA is expected to decide on the filing in September 2021. Additionally, the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.  AVT02 is a proposed biosimilar to the reference product HUMIRA® (adalimumab) with high concentration (100mg/mL) dosage forms that are expected to be beneficial to patients and to be differentiated from most biosimilar competitors, while matching the newest dosage forms of the reference product.  

“We are excited to announce that our filing for AVT02 has been accepted for review. This is the next important step in our progression to realizing our goals of getting important medicines to more patients around the world. This is also an important milestone for Alvotech and aligns with our mission to accelerate the introduction and adoption of new biosimilars. The filings were based on the results of a comprehensive development program and data package comprising of a totality of evidence demonstrating a high degree of similarity of AVT02 compared to its reference product.”

Joseph E. McClellan

Chief Scientific Officer

A summary of the key elements includes:

  • AVT02 is highly similar to its reference product in terms of structure and function, which was assessed using a comprehensive set of state-of-the-art and orthogonal analytical methods.
  • PK similarity of AVT02 to its reference product was established in the comparative PK Study AVT02-GL-101 following subcutaneous (SC) administration of AVT02 or the reference products to healthy subjects at a single dose of 40 mg.
  • The comparative clinical efficacy and safety Study AVT02-GL-301 established the therapeutic equivalence of AVT02 to its reference product in the sensitive population of subjects with moderate to severe chronic psoriasis with similar efficacy, and comparable safety, tolerability, and immunogenicity profiles.

“The comprehensive AVT02 development program has demonstrated key results comparatively to the reference product and we are extremely happy to have met our primary objectives in regards to efficacy, safety and PK similarities. This is reflected in our evidence-based dossier and we are looking forward to concluding the regulatory decisions soon and enabling valuable access to medicine for patients around the world.”

Kimber Poffenberger

Senior Vice President and Global Head of Regulatory Affairs

AVT02 is one of five product candidates from Alvotech that will be commercialized, upon approval, by Teva Pharmaceuticals in the U.S. following an exclusive strategic partnership announced earlier this year. This strategic partnership combines Teva’s long-standing commercial presence and extensive infrastructure in the U.S. market with Alvotech’s scientific experience and state-of-the-art biologics manufacturing.

AVT02 is one of seven product candidates from Alvotech that will be commercialized by STADA in all key European markets and selected markets outside Europe following an exclusive strategic partnership announced in 2019.

About Alvotech

Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotech’s shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Robert Wessman, Fuji Pharma from Japan, Shinhan from Korea, Baxter Healthcare SA, YAS Holdings, ATHOS (Strüngmann Family Office), CVC Capital Partners and Temasek from Singapore.

Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world.

About AVT02

AVT02 is a monoclonal antibody (mAb) and a proposed biosimilar to HUMIRA® (adalimumab). AVT02 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.

About AVT-GL-101

AVT02-GL-101 is a multicenter, randomized, double-blind, 3-arm, parallel study to compare the pharmacokinetics, safety and tolerability of AVT02  to EU-approved and US-licensed  HUMIRA® administered as a single dose (40 mg Subcutaneous Injection) in healthy adult volunteers.  According to the study protocol, a total of 392 subjects were randomized.  The primary objective of the AVT02-GL-101 study is to compare the PK of AVT02 with EU-HUMIRA® and US-HUMIRA®, and the PK of EU- HUMIRA® and US- HUMIRA®, following a single 40 mg subcutaneous (SC) injection in healthy adult volunteers.  The secondary objectives of this study are to assess the safety, tolerability, and immunogenicity of AVT02 to EU- HUMIRA® and US- HUMIRA®. Results of the study indicate that there is no clinically meaningful difference between AVT02, US- HUMIRA® and EU- HUMIRA® in the safety, tolerability, and immunogenicity outcome measures.

About AVT-GL-301

AVT02-GL-301 study is a multicenter, double-blind, randomized, parallel-group, active control study to compare the efficacy, safety, and immunogenicity of AVT02 versus HUMIRA® in patients with moderate-to-severe chronic plaque psoriasis.  A total of 412 patients were enrolled into the study.  The primary objective is to assess the therapeutic equivalence by Psoriasis Area and Severity Index (PASI) of AVT02 to EU-HUMIRA® with regards to efficacy at Week 16.  Secondary objectives include safety, tolerability, immunogenicity and serum trough levels at steady state, through the entire study duration.  More information about the AVT02-GL-301 study can be found at