FDA’s Gottlieb launches biosimilars action plan
The US Food and Drug Administration (FDA) is not going to play regulatory ‘whack-a-mole’ with companies trying to delay or derail the entry of biosimilar competitors, according to Scott Gottlieb, commissioner of the FDA.
“We’re not going to wait a decade or more for robust biosimilar competition to emerge,” added Gottlieb, who was speaking at Brookings Institution (a research group) yesterday, July 18.
Gottlieb released the FDA’s biosimilars action plan, a four-part strategy aimed at strengthening sales of biosimilars (copies of biologic drugs where the active ingredient is made by an engineered organism).
The four-part plan consists of improving the efficiency of the biosimilar development and approval process; maximising scientific and regulatory clarity; developing effective communications to improve understanding among patients, clinicians and payors; and supporting market competition by reducing gaming.
This plan is part of the FDA’s blueprint to lower drug prices and facilitate the entry of generic and biosimilar drugs into the US market.
“At the FDA, we recognise the critical role Congress has given us to make sure the US maintains a robust market for new biologics innovation, while also advancing paths that promote timely biosimilar competition to enhance patient access and reduce costs for patients and our healthcare system,” said Gottlieb.
Although the FDA has approved 11 biosimilars in total, just three are marketed in the US, making the competition “anaemic” for the most part, according to the FDA commissioner.
He added: “It’s anaemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the US several years before they’ll be available to patients here. These delays can come with enormous costs for patients and payors.”
While biologic manufacturers have the right to defend their IP interests, said Gottlieb, rebate schemes and “patent thickets” that are designed purely to deter the entry of biosimilars are spoiling competition.
The FDA will be updating guidance to provide more clarity on how biosimilar makers can carve out indications from their labels where a branded drug maker might maintain some IP.
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