USFDA accelerates biosimilar approvals process in the US — Four stocks that could benefit

The United States Food and Drug Administration (USFDA) has issued new draft guidelines to simplify and speed up the biosimilar drug development process in the US.

The move is intended to make biosimilars emerge as a lower cost alternative to biologics, and will also be faster and cheaper to bring to the market.

Such a move will be positive for Indian drugmakers such as Biocon, Dr. Reddy's Laboratories, Lupin and Sun Pharma, who have exposure to the biosimilars market in the US.

The draft regulations reduce the requirement for costly, low-yield comparative efficacy studies, and allows reliance on analytical testing instead of large clinical trials.

The recommendation for "Switching studies" for interchangeable biosimilars has also been dropped as part of the draft guidelines.

Biologics