istock-679546546ildo-frazao
Ildo Frazao / iStockphoto.com
19 July 2018Americas

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.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
Americas
26 October 2018   The US Food and Drug Administration’s generic drug approval rate has increased at a “rapid rate” since January 2017, despite the number of branded drug patent expirations declining during this period.
Americas
6 March 2019   Scott Gottlieb, commissioner of the US Food and Drug Administration, resigned from his post yesterday, March 5, with plans to step down in the next month.

More on this story

Americas
11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
Americas
26 October 2018   The US Food and Drug Administration’s generic drug approval rate has increased at a “rapid rate” since January 2017, despite the number of branded drug patent expirations declining during this period.
Americas
6 March 2019   Scott Gottlieb, commissioner of the US Food and Drug Administration, resigned from his post yesterday, March 5, with plans to step down in the next month.

More on this story

Americas
11 October 2018   The US Food and Drug Administration has released guidance intended to advance the development of generic versions of complex medical drugs.
Americas
26 October 2018   The US Food and Drug Administration’s generic drug approval rate has increased at a “rapid rate” since January 2017, despite the number of branded drug patent expirations declining during this period.
Americas
6 March 2019   Scott Gottlieb, commissioner of the US Food and Drug Administration, resigned from his post yesterday, March 5, with plans to step down in the next month.