Topics

FDA issues draft guidance on licensing biosimilars for fewer indications

04:04 EST 14 Feb 2020 | Generics and Biosimilars Initiative

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.

Original Article: FDA issues draft guidance on licensing biosimilars for fewer indications

NEXT ARTICLE

More From BioPortfolio on "FDA issues draft guidance on licensing biosimilars for fewer indications"

Quick Search

Relevant Topic

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...