AGC Biologics Achieves FDA Approval for Biosimilar at Copenhagen Facility

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced that its Copenhagen Campus has achieved U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar designed to treat conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This marks a significant milestone for the Copenhagen site and underscores the company's growing influence in the biosimilar market.

The expiration of patents for biologic products is encouraging new entrants into the biosimilar market, offering lower-cost alternatives for patients. The market for this drug segment is projected to exceed $126 billion by 2032, growing at a compound annual growth rate (CAGR) of 17.6% from 2023 to 2032, according to a 2023 report.

AGC Biologics attributes its success in gaining FDA approval to its resources for biosimilar developers, which include flexible and scalable single-use manufacturing technology, scalable production capabilities based on market demand, and strong expertise in managing quality control requirements. These factors were crucial in guiding the new product to FDA commercial approval.

Christoph Winterhalter, Chief Business Officer at AGC Biologics, noted, “We have one of the most extensive single-use technology bioreactor networks in the world. This allows us to start with the 2,000 L scale for product launch and scale out to larger batch sizes based on product demand. This economies-of-scale production model increases production for biosimilars as demand grows while saving costs for our partners.”

Andrea Porchia, General Manager of AGC Biologics Copenhagen, added, “This latest FDA achievement at our site demonstrates why we have been so successful. I continue to be impressed by this site and our team’s commitment to quality, productivity, and helping partners achieve their goals.”

The FDA approval follows the recent completion and opening of a new manufacturing building at the Copenhagen site, which has more than doubled its single-use bioreactor capacity. The new 19,000 m2 facility features an expanded manufacturing floor, enhanced quality control and process development lab space, and added utilities to support all operations at the site.

AGC Biologics’ Copenhagen site boasts a team of scientists with over 25 years of experience in biopharmaceutical development and manufacturing, including bringing seven commercial products to market. The site offers pre-clinical through commercial production for protein biologics using mammalian and microbial systems and has a gold EcoVadis Sustainability Rating for its environmental, health, and sustainability practices.