AGC Biologics Strengthens Portfolio with Latest FDA Commercial Approval at Company’s CPH Facility

CDMO expands commercial track record for biosimilar manufacturing

Today, we announce the newest milestone at our Copenhagen Campus, a U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar indicated for psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. This is our latest commercial biosimilar approval, and a new milestone for its Copenhagen site.

The expiration of patents for biologics products is driving new players to enter the biosimilar market and offer lower-cost alternatives for patients. Market value for this drug segment is expected to be more than $126 billion by 2032, a 17.6 percent CAGR between 2023 and 2032, according to a 2023 report. AGC Biologics offers key resources for biosimilar developers, such as flexible and scalable single-use manufacturing technology, the ability to scale production based on market demand, and strong expertise in managing quality control requirements needed to advance in each clinical phase. All these characteristics led to our Copenhagen site guiding this new product to FDA commercial approval.

"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 and utilize added vessels to reach larger batch sizes of 4,000 L, 6,000 L, 8,000 L etc. based on product demand in later phases. Through this economies-of-scale production model, we increase production for biosimilars as demand grows, while saving costs for our partners," said Christoph Winterhalter, Chief Business Officer, AGC Biologics. "When you combine this element with our scientific quality expertise that emphasizes finding the Quality Target Product Profile (QTPP) - we are one of the best CDMOs available to help biosimilar developers meet clinical and commercial goals."

"This latest FDA achievement at our site demonstrates why we have been so successful," notes Andrea Porchia, General Manager, AGC Biologics Copenhagen. "I continue to be impressed by this site and our team's commitment to quality, productivity and helping partners achieve their goals. We look forward to helping to produce this important treatment and provide patients in need with a new option to choose from than what has been historically available."

The new commercial approval in the U.S. for this product comes after the Copenhagen site announced the completion and opening of a new manufacturing building at our site in June, which more than doubled our single-use bioreactor capacity. The new 19,000 m2 ultramodern building offers a larger manufacturing floor, expanded quality control and process development lab space, and added utilities to support all operations at the site.

Our Copenhagen site's core team of scientists has more than 25 years of expertise in biopharmaceutical development and manufacturing, including seven commercial products brought to market. The site offers pre-clinical through commercial production for protein biologics services using mammalian and microbial systems and has a gold EcoVadis Sustainability Rating for its environmental, health and sustainability practices.

To learn more about AGC Biologics' protein biologics manufacturing site in Copenhagen, visit https://www.agcbio.com/facilities/copenhagen . For more information on our end-to-end global CDMO services in Europe, Japan and the U.S. visit www.agcbio.com.