AGC Biologics Achieves FDA Approval for Biosimilar at Copenhagen Facility

AGC Biologics, a global leader in biopharmaceutical contract development and manufacturing, has announced a significant advancement in its capabilities with the recent U.S. Food and Drug Administration (FDA) commercial approval for a biosimilar at its Copenhagen facility. This approval marks a crucial step in the company's expansion and solidifies its position in the rapidly growing biosimilar market.

The newly approved biosimilar is indicated for treating several autoimmune conditions, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This development comes at a time when the biosimilar market is experiencing substantial growth, with projections indicating a market value exceeding $126 billion by 2032, representing a compound annual growth rate of 17.6 percent from 2023 to 2032.

The approval highlights AGC Biologics' expertise in navigating the complex regulatory landscape for biosimilars. The company's Copenhagen site played a pivotal role in guiding the product through the FDA approval process, leveraging its extensive experience in biopharmaceutical development and manufacturing.

Christoph Winterhalter, Chief Business Officer at AGC Biologics, emphasized the company's unique positioning in the biosimilar market. "We have one of the most extensive single-use technology bioreactor networks in the world," Winterhalter stated. This technology allows for flexible scaling of production, starting from 2,000 L and expanding to larger batch sizes as demand increases, providing a cost-effective solution for biosimilar developers.

The company's approach combines scalable manufacturing capabilities with scientific quality expertise, focusing on identifying the Quality Target Product Profile (QTPP). This strategy positions AGC Biologics as a preferred partner for biosimilar developers aiming to meet both clinical and commercial objectives.

Andrea Porchia, General Manager of AGC Biologics Copenhagen, highlighted the site's commitment to quality and productivity. The recent FDA approval follows the completion of a new manufacturing building at the Copenhagen site in June, which more than doubled its single-use bioreactor capacity. This expansion, covering 19,000 m2, includes enhanced manufacturing facilities, expanded quality control and process development lab space, and improved utilities to support all operations.

The Copenhagen site's achievements are backed by over 25 years of expertise in biopharmaceutical development and manufacturing, with a track record of bringing seven commercial products to market. The facility's capabilities extend to both mammalian and microbial production systems, catering to a wide range of biopharmaceutical needs.

AGC Biologics' success in obtaining FDA approval for this biosimilar is particularly significant given the growing importance of biosimilars in the pharmaceutical industry. As patents for biologic products expire, biosimilars offer more affordable alternatives for patients, potentially increasing access to critical treatments for autoimmune and inflammatory conditions.

The company's global presence, with facilities across Europe, Japan, and the U.S., positions it to meet the increasing demand for biosimilar development and manufacturing. AGC Biologics' commitment to innovation and specialization in fast-track projects and rare diseases further enhances its appeal to partners in the biopharmaceutical industry.

This latest approval not only strengthens AGC Biologics' portfolio but also contributes to the broader goal of expanding access to critical medications through the development of high-quality biosimilars. As the biosimilar market continues to grow, AGC Biologics is well-positioned to play a crucial role in bringing these important treatments to patients worldwide.

For more information on AGC Biologics' protein biologics manufacturing capabilities, interested parties can visit https://www.agcbio.com/facilities/copenhagen. Additional details about the company's global CDMO services are available at www.agcbio.com.