AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar drug produced at its Copenhagen facility. This biosimilar is indicated for the treatment of psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The approval marks a notable advancement for AGC Biologics' operations in Copenhagen and highlights the company's expanding capabilities in the biosimilar market.
The expiration of patents for biologic products has opened the door for new entrants in the biosimilar market, offering lower-cost alternatives for patients. According to a 2023 report, the market value for biosimilars is expected to exceed $126 billion by 2032, growing at a compound annual growth rate (CAGR) of 17.6% from 2023. AGC Biologics stands out in this competitive landscape by providing essential resources for biosimilar developers, including flexible and scalable single-use manufacturing technology, the capacity to adjust production levels based on market demand, and robust expertise in managing quality control requirements through each clinical phase.
Christoph Winterhalter, Chief Business Officer at AGC Biologics, emphasized the company's state-of-the-art single-use technology bioreactor networks, which allow for scalable production from 2,000 liters to larger batch sizes as demand increases. “This economies-of-scale production model enables us to ramp up biosimilar production efficiently while reducing costs for our partners,” Winterhalter stated. Additionally, AGC Biologics' scientific expertise in determining the Quality Target Product Profile (QTPP) further solidifies its position as a premier CDMO for biosimilar developers aiming to meet clinical and commercial objectives.
Andrea Porchia, General Manager of the Copenhagen facility, reflected on the team's dedication to quality and productivity. “This latest FDA approval showcases our commitment to excellence and our ability to support partners in achieving their goals,” Porchia noted. The newly approved biosimilar provides patients with additional treatment options beyond those traditionally available.
This FDA approval comes on the heels of the completion and opening of a new manufacturing building at AGC Biologics' Copenhagen site in June. The new 19,000 square meter facility has more than doubled the site's single-use bioreactor capacity and features an expanded manufacturing floor, enhanced quality control and process development lab space, and additional utilities to support operations.
AGC Biologics' Copenhagen site is renowned for its expertise in biopharmaceutical development and manufacturing, with over 25 years of experience and seven commercial products brought to market. The site offers comprehensive services from pre-clinical to commercial production using mammalian and microbial systems and has been recognized with a gold EcoVadis Sustainability Rating for its environmental, health, and sustainability practices.
The FDA approval not only enhances AGC Biologics' portfolio but also underscores the company's role in advancing the biosimilar market, providing cost-effective and high-quality therapeutic options for patients worldwide.
