NDA to BLA Transition Hits Compounders, Authorized Generics

Regulatory NewsRegulatory News | 05 March 2020 |  By 

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.

Authorized Generics Become Authorized Biosimilars

In addition, questions have circulated about what will happen to the cheaper, authorized generic versions of Eli Lilly and Novo Nordisk’s insulin products when the March deadline hits. And experts told Focus that the “authorized generic” insulins will still be available and have their own national drug code, but because they will not be considered interchangeables, they would not be automatically substitutable at the pharmacy or in the hospital.

They will not be considered interchangeable because Wednesday’s guidance explains how biosimilars cannot gain an interchangeable designation unless they are licensed under 351(k) pathway, and companies cannot reference their own products if they seek approval under the 351(k) pathway.

But moving forward, a biopharma company that owns a biologic reference product could still market an authorized copy of its own reference product under the original BLA, which, like authorized generics (which are not actually generic drugs but just a differently labeled version of the brand name drug), could be known as “authorized biosimilars,” even though they are not really biosimilars but would be the same product as the reference product.

Notice to Compounders: Changes that affect compounding as of March 23, 2020


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