USA – New guidance on biologics affects authorized generics

In less than three weeks, the US Food and Drug Administration (FDA) will officially transition more than 100 new drug applications (NDAs) to biologics license applications (BLAs), which will not only impact biopharma companies but also drug compounders.

This transition, dubbed the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009, was further explained in guidance finalized on Wednesday. Part of that guidance explains how biopharma companies with deemed BLAs will not have to update their labeling of biological products marketed under a deemed BLA until 23 March 2025.

But for compounders, also known as outsourcing facilities, changes may be coming more quickly.

According to FDA, “Outsourcing facilities have recently reported using four bulk drug substances that are affected by the transition: human chorionic gonadotropin, hyaluronidase, follicle stimulating hormone (FSH or urofollitropin) and menotropins.”

However, hyaluronidase was included in category 1 of the list of substances under the agency’s 503B bulks interim policy

“As stated in the 503 bulks interim policy, biological products subject to approval under section 351 of the PHS Act are not eligible for the 503B bulks list because such products are not eligible for the exemptions in section 503B of the FD&C Act. Accordingly, as of March 23, hyaluronidase will be removed from category 1,” FDA said…