Public-Private partnership in biologic drug development

A paper from Nayak et al. (2021) in JAMA Internal Medicine describes how public-private partnerships have helped bring new biologic drugs to market. Using data on new biologic drugs approved by the FDA’s Center for Drug Evaluation and Reseach (CDER) and US patent office data, the authors find that:

Twenty-nine drugs (42%) showed evidence of late-stage contributions from public-sector institutions (24) or originated from a public-sector spin-off company (5)…Eight were identified from an assigned patent, and the remainder from a monograph (10) or investigation of the drug development history (11). We found evidence of a relevant patent, licensing agreement, or royalty agreement held by a public-sector institution for 24 drugs. Of the remaining 5 drugs, 3 were developed and directly manufactured by the UK Health Protection Agency (no US patents identified), and 2 were developed with the direct assistance of the US government via the Biomedical Advanced Research and Development Authority or National Institutes of Health for financing of pivotal clinical trials or manufacturing.

The authors note that public support for biologics (42%) is higher than what is observed for small molecules (25%). This finding should not be surprising as biologic drugs are typically more complex to discover and manufacture than small molecules. Note that the study did not examine vaccines, gene therapies or CAR-T therapies.

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