The transition is part of the ‘deemed to be a license’ provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which created an abbreviated approval pathway for biosimilars.

FDA issued a final rule on a definition of the term ‘biological product’ in February 2020 [1], which will become effective from 23 March 2020. On this date around 100 products approved under NDAs will transition to BLAs.

In further guidance released on 4 March 2020, FDA explained that biotechnology firms with deemed BLAs will not need to update their labelling of biological products under a deemed BLA until 23 March 2025.

However, there may be more rapid changes for compounders (aka outsourcing facilities) who, according to FDA, have reported using the following four bulk drug substances that are affected by the transition:

• Human chorionic gonadotropin
• Follicle stimulating hormone
• Menotropin (all of which are fertility treatments)
• Hyaluronidase, used to accelerate the delivery of drugs

Furthermore, Hyaluronidase which was included in category 1 (bulk drug substances under evaluation) of FDA’s 503B bulk interim policy (an interim policy on which bulk drug substances outsourcing facilities can and cannot use in compounding) is to be removed from this category.

FDA says: ‘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 23 March 2020, hyaluronidase will be removed from category 1.’

It is unclear what this change means for the lower-priced insulin products made available by Eli Lilly [2] and Novo Nordisk [3], which are currently classified as ‘authorized generics’.

There are concerns that, because these products will not be considered as interchangeable, they will not be automatically substitutable. FDA states that biosimilars cannot gain an interchangeable designation unless they are licensed under the 351(k) pathway and companies cannot reference their own products if they seek approval under the 351(k) pathway.

However, a company that owns a reference biological could market a copy of that product under the original BLA, which could then be known as an ‘authorized biosimilar’.

Related articles
Comments on FDA’s plans to transition insulin products

FDA issues final guidance on interchangeable biologicals

Biosimilars approved in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues new rule on definition of term ‘biological product’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Guidelines/FDA-issues-new-rule-on-definition-of-term-biological-product
2. GaBI Online - Generics and Biosimilars Initiative. Eli Lilly launches lower-priced insulin lispro [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/General/Eli-Lilly-launches-lower-priced-insulin-lispro
3. GaBI Online - Generics and Biosimilars Initiative. Novo Nordisk to launch biosimilar insulin in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/General/Novo-Nordisk-to-launch-biosimilar-insulin-in-the-US

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