Curated News
By: NewsRamp Editorial Staff
August 28, 2024
AGC Biologics Achieves FDA Approval for Biosimilar in Copenhagen
Discuss on Reddit
Discuss on LinkedIn
Discuss on SubstackTLDR
- AGC Biologics secures FDA approval for psoriasis biosimilar, positioning itself in the lucrative biosimilar market.
- AGC Biologics utilizes single-use bioreactor technology to scale production for biosimilars, meeting market demand and quality control requirements.
- The FDA approval for AGC Biologics' biosimilar provides patients with lower-cost alternatives, improving access to treatment for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
- AGC Biologics' FDA approval showcases the growing importance of biosimilars in the pharmaceutical industry, offering new options for patients and developers.
Impact - Why it Matters
This news matters because it represents a significant milestone for AGC Biologics and the biosimilar market, offering lower-cost alternatives for patients. With the expected market value for biosimilars to reach over $126 billion by 2032, this achievement demonstrates the company's commitment to providing high-quality, cost-effective treatment options for patients in need.
Summary
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has achieved FDA commercial approval for a biosimilar indicated for psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis at its Copenhagen Campus. The company's extensive single-use technology bioreactor network and scientific quality expertise were key factors in guiding this new product to FDA commercial approval. The Copenhagen site has also completed a new ultramodern manufacturing building, doubling its single-use bioreactor capacity, and has core teams of scientists with over 25 years of expertise in biopharmaceutical development and manufacturing.
Source Statement
This curated news summary relied on this press release disributed by News Direct. Read the source press release here, AGC Biologics Achieves FDA Approval for Biosimilar in Copenhagen
