Subscribe
shutterstock_1086968018_jarretera-2
Jarretera / Shutterstock.com
13 May 2019Americas

Diabetics to benefit under latest FDA biosimilar guidance

The Food and Drug Administration (FDA) has issued final guidance on the pathway for ‘interchangeable’ biosimilar products, in a bid to promote competition in the biologics market.

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

article
FDA to alter biosimilar ‘suffix’ policy
8 March 2019   The US Food and Drug Administration yesterday announced draft revisions to its policy on the naming of biosimilars, in an attempt to appease critics who say that renaming previously-licensed products is too expensive.
Biotechnology
FDA releases plan to boost biosimilars development
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Americas
US Congress confirms new drug patent listing law
22 December 2020   A $2.3 trillion spending bill passed by the US Congress yesterday, December 21 includes a proposed change to the laws concerning biologic drugs.


Editor's picks

Europe
UPC confirms validity of Edwards Lifesciences heart valve tech patent
23 July 2024

Editor's picks

Europe
UPC confirms validity of Edwards Lifesciences heart valve tech patent
23 July 2024
Americas
New-look WIPR Leaders 2024 is ‘most rigorous’ yet
2 July 2024
Americas
Earthquake Chevron: A massive shock to the system?
2 July 2024
Americas
Amarin wins appeal to advance ‘skinny label’ suit over Hikma generic
27 June 2024
Biotechnology
Guardant Health files suit against Tempus AI
13 June 2024
Big Pharma
Roche fires lawsuit at Sinocare unit over blood glucose test strip patents
6 June 2024

More on this story

article
FDA to alter biosimilar ‘suffix’ policy
8 March 2019   The US Food and Drug Administration yesterday announced draft revisions to its policy on the naming of biosimilars, in an attempt to appease critics who say that renaming previously-licensed products is too expensive.
Biotechnology
FDA releases plan to boost biosimilars development
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Americas
US Congress confirms new drug patent listing law
22 December 2020   A $2.3 trillion spending bill passed by the US Congress yesterday, December 21 includes a proposed change to the laws concerning biologic drugs.

More on this story

article
FDA to alter biosimilar ‘suffix’ policy
8 March 2019   The US Food and Drug Administration yesterday announced draft revisions to its policy on the naming of biosimilars, in an attempt to appease critics who say that renaming previously-licensed products is too expensive.
Biotechnology
FDA releases plan to boost biosimilars development
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Americas
US Congress confirms new drug patent listing law
22 December 2020   A $2.3 trillion spending bill passed by the US Congress yesterday, December 21 includes a proposed change to the laws concerning biologic drugs.

More features

Chinese biotech takes out US rival’s nucleic acid patent at PTAB
Attorney v examiner: Navigating patenting's AI tools ‘arms race’
Lewis Roca promotes tech expert to managing partner
Panitch Schwarze brings in molecular biologist
US targets ‘product hopping’ with biologic litigation curbs
UPC confirms validity of Edwards Lifesciences heart valve tech patent
ITC concludes row over biotech lab equipment between US and German rivals
UKIPO launches ‘revolutionary’ patent filing and AI tool