Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug?utm_campaign=111519_Statement_FDA%20facilitating%20competition%20with%20approval%20of%2025th%20biosimilar&utm_medium=email&utm_source=Eloqua

Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product 

Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, and microorganisms such as bacteria or yeast, and developed using advanced science. They are usually more complex than other drugs and are particularly critical in the treatment of cancer and autoimmune conditions, such as rheumatoid arthritis, psoriasis and inflammatory bowel disease. Historically, biologics lacked effective competition in the marketplace because there was no abbreviated FDA review pathway for bringing “follow-on” versions of biologics to market. That changed when Congress gave FDA the authority to implement an abbreviated approval pathway for biosimilar and ...

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