Subscribe
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.

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
FDA issues guidance on generic versions of complex drugs
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
FDA improves generic approval rate under Trump: report
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
FDA chief Gottlieb resigns after nearly two years
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.


Editor's picks

Americas
Amgen set for ‘at-risk’ launch of blockbuster eye drug biosimilar
24 October 2024

Editor's picks

Americas
Amgen set for ‘at-risk’ launch of blockbuster eye drug biosimilar
24 October 2024
Asia
President Xi sends message to AIPPI’s World Congress
22 October 2024
Unified Patent Court
‘Every CMS filing is painful’: Notes from a Unified Patent Court dispute
26 September 2024
Unified Patent Court
Interview: Klaus Grabinski, UPC Court of Appeal president
24 September 2024
Unified Patent Court
‘Be prepared, and don’t assume at the UPC’: Christopher Stothers
12 September 2024
Unified Patent Court
Does the UPC offer a fresh take on patent validity?
5 September 2024

More on this story

Americas
FDA issues guidance on generic versions of complex drugs
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
FDA improves generic approval rate under Trump: report
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
FDA chief Gottlieb resigns after nearly two years
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
FDA issues guidance on generic versions of complex drugs
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
FDA improves generic approval rate under Trump: report
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
FDA chief Gottlieb resigns after nearly two years
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 features

President Trump 2.0: Five major areas to watch
China’s new policies on foreign investment in healthcare and biotech
Startup CFO’s betrayal is a lesson in preparing for the worst
Sandoz lands reduced antitrust award of $70m
New president’s to-do list: Patent bills, non-competes, USPTO director?
Sanofi subsidiary fends off $450m trade secrets case
Regulatory expert joins White & Case
Teva faces $500m fine for antitrust breaches over MS drug