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Alvotech receives manufacturing license for its Biopharmaceutical facility

25 September 2018

Alvotech is delighted to announce that it has received manufacturing licensure from the Icelandic Medicines Agency, for its biopharmaceutical facility in Reykjavik, Iceland. The 13,000m² facility, located in the science park of the University of Iceland in Reykjavik, is dedicated to the development and manufacturing of Alvotech’s broad biosimilar portfolio.

Alvotech is a global biopharmaceutical company with a pipeline of high value and quality biosimilar product candidates. The granting of the manufacturing license by the Icelandic Medicines Agency, in consultation with the Irish Health Products Regulatory Authority, is a significant milestone for Alvotech and confirms compliance with the principles and guidelines of Good Manufacturing Practices (GMP) laid out in directive 2003/94/EC.

Rojkjaer Rasmus, CEO of Alvotech, commented:

“The issuance of the manufacturing license from the Icelandic Medicines Agency is another important milestone on our journey to providing patients with more easily accessible and affordable high-quality biopharmaceuticals.”

“It’s the product of a lot of hard work by the Alvotech team and reflects our commitment to becoming a leading player in the biosimilar industry. With a full-scale best-in-class manufacturing capability, we are well positioned to take on opportunities in the global biosimilar market.”