FDA’s First Biosimilar Approval Greeted With Optimism; Naming, Pricing Still Issues

Attorneys greeted the FDA’s first approval of a biosimilar using the abbreviated approval pathway under the Biologic Price Competition and Innovation Act (BPCIA) as a good first step but cautioned that the agency picked “low-hanging fruit.”

“What it shows is that biosimilar approval can be achieved for a relatively simple protein that has been on the market as a brand in the U.S. and as a biosimilar in Europe for a while,” Stacie Ropka of Axinn, Veltrop & Harkrider, Hartford, Conn., told Bloomberg BNA in a March 9 phone interview. Pending abbreviated biologics applications (aBLAs) for more complex drugs may ...