Lilly, Regeneron among firms chosen for FDA fast plant pilot

Eli Lilly, Regeneron, and five other companies have been selected to take part in the FDA's PreCheck pilot programme, designed to make it easier and quicker to set up US manufacturing facilities.

The programme is part of a push to persuade more drugmakers to manufacture medicines intended for the American public in domestic production plants, which has already persuaded a swathe of big pharma groups to promise tens of billions of dollars in US-based capital investment projects in order to avoid tariffs on imported medicines.

The FDA – which has also selected facilities from Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin for the pilot – said the aim is to "boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the US drug supply chain."

First announced last summer, PreCheck will introduce a two-phase approach to getting approval for new production sites.

The first is promising to provide quicker responses from the agency on start-up tasks like plant design, construction, and pre-production, while the second is predicated on speeding up reviews of the chemistry, manufacturing, and controls (CMC) section of new facility applications, through greater interactions with the agency.

The FDA said it received more than 80 requests to take part in the pilot phase.

Lilly's involvement in the pilot revolves around an active pharmaceutical ingredient (API) plant for "existing and future medicines" at its campus in Lebanon, Indiana, which it recently said would benefit from a $4.5 billion investment on top of a $27 billion programme announced last year, according to the FDA, while Regeneron's facility in Saratoga Springs, New York will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics.

Amneal's facility in Long Island, New York will manufacture small molecule sterile liquid products for pain management, respiratory, and ophthalmic diseases, while Cellares is entering a plant in Bridgewater, New Jersey, that will make cell-based gene therapy products for oncology and haematology indications.

The final three involved in the pilot, all located in North Carolina, are Fujifilm's cell culture biomanufacturing facility in Holly Springs, Kriya's Durham unit for AAV-based gene therapy products, and a Kyowa Kirin plant in Sanford that will manufacture biotechnology drug substances for rare diseases.

PreCheck is one of several measures designed to make capital investment projects easier for pharma in the US, along with fast-track reviews for generics tested and made in domestic facilities and a priority voucher scheme for medicines deemed to be of national priority, cutting their review time from 10-12 months to a few weeks.

It has been suggested that the companies that stand to benefit the most from the fast-track will be smaller companies that lack the financial muscle to absorb a lot of investment risk and can benefit from closer collaboration with the FDA.

Image by Manuel Alvarez from Pixabay