Guidelines

FDA rejects petitions over biologicals naming guideline

Home/Guidelines | Posted 17/02/2017

The US Food and Drug Administration (FDA) has rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same non-proprietary names as their reference products.

New FDA guidance to speed up generics approvals

Home/Guidelines | Posted 10/02/2017

Updated guidance released by the US Food and Drug Administration (FDA) renews the criteria for receiving generic drug applications and downgrades certain deficiencies to ease the pressure on industry.

FDA issues final guidance on naming biologicals

Home/Guidelines | Posted 27/01/2017

The US Food and Drug Administration (FDA) has issued final guidance detailing the agency’s requirements for the non-proprietary naming of biological products.

FDA issues draft guidance on biosimilar interchangeability

Home/Guidelines | Posted 20/01/2017

The US Food and Drug Administration (FDA) has finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals.

FDA issues final guidance on pharmacology data for biosimilarity

Home/Guidelines | Posted 13/01/2017

The US Food and Drug Administration (FDA) on 29 December 2016 published final guidance outlining the clinical pharmacology data necessary to support a biosimilar application.

Biosimilars interchangeability guidance expected by end 2017

Home/Guidelines | Posted 14/10/2016

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.

FDA issues final guidance on pharmacology labelling

Home/Guidelines | Posted 09/12/2016

The US Food and Drug Administration (FDA) on 2 December 2016 published final guidance for completing the clinical pharmacology section of labelling for human prescription drugs, which includes originator drugs, generics and biologicals.

FDA releases 67 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 18/11/2016

As part of its ongoing efforts to provide product specific guidance for generics makers the US Food and Drug Administration (FDA) has again released a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

FDA issues guidance on self-identification for generics makers

Home/Guidelines | Posted 04/11/2016

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

Regulations for biosimilars in South Korea

Home/Guidelines | Posted 10/04/2015

The legislative basis for the regulation of biosimilars and its guideline for evaluation of biosimilars in South Korea was established in 2009 [1, 2].