Alvotech, a global biotech company dedicated to developing and manufacturing biosimilar medicines to benefit patients worldwide, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in relation to its Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab).
The CRL noted that certain deficiencies identified in a recent reinspection at the company’s Reykjavik facility must be resolved before the application can be approved. Alvotech has already provided comprehensive responses to the FDA’s observations and is now awaiting further communication from the agency.
Alvotech’s second BLA for AVT02, which includes data to support approval as a biosimilar and additional information to support potential interchangeability designation, is currently being reviewed by the FDA with a Biosimilar User Fee Amendment (BsUFA) goal date of June 28, 2023. The successful completion of the facility reinspection is essential for achieving approval.
Alvotech is eager to collaborate with the FDA to address any questions from the reinspection. Robert Wessman, Chairman and CEO of Alvotech, is devoted to manufacturing AVT02 for the benefit of patients in the United States, especially through a unique Humira biosimilar with a high-concentration formula that is interchangeable.
AVT02 is an innovative monoclonal antibody that has been approved as a biosimilar to Humira® (adalimumab) in an impressive 27 countries across Europe, the UK, Canada, Australia, Saudi Arabia, and more! It is currently available in 16 countries and further dossiers are under review, including in the United States. This marks a major breakthrough for medical science and for those seeking more affordable treatment options.
Alvotech is a biotech pioneer, established by Robert Wessman, that is committed to the development and manufacture of biosimilar medicines to improve the lives of patients around the world.
As a leader in the biosimilar space, Alvotech is devoted to providing high quality and cost-effective products and services, through its fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline consists of eight biosimilar candidates to treat autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer.
To extend its global reach, Alvotech has joined forces with renowned commercial partners, including Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, Advanz Pharma, Cipla/Cipla Gulf/Cipla Med Pro, JAMP Pharma Corporation, Yangtze River Pharmaceutical (Group) Co., Ltd., DKSH, YAS Holding LLC, Abdi Ibrahim, Kamada Ltd., Mega Labs, Stein, Libbs, Tuteur and Saval, and Lotus Pharmaceuticals Co., Ltd.
These commercial partnerships cover a variety of products and territories, and Alvotech takes full responsibility for the content of periodic filings, disclosures and other reports made available by its partners