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.”