Guidelines

FDA releases 37 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 14/07/2017

As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents. The agency announced on 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.

FDA asks for comments on reauthorization of BsUFA

Home/Guidelines | Posted 07/07/2017

The US Food and Drug Administration (FDA) is seeking public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication (Program) for original biologics license applications (BLAs). The program is part of the FDA’s commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA).

Apotex petitions FDA over Neulasta biosimilars

Home/Guidelines | Posted 19/05/2017

Apotex, and its specialist biosimilars unit Apobiologix, submitted a Citizen Petition on 21 April 2017 to the US Food and Drug Administration (FDA). The petition requests that the agency requires all biosimilar applicants referencing Neulasta (pegfilgrastim) to ‘conduct their comparative clinical efficacy studies (including pharmacokinetics (PK) and pharmacodynamics (PD) studies and immunogenicity studies) in at least one intended patient population’.

EMA biosimilars guidance for healthcare professionals

Home/Guidelines | Posted 12/05/2017

The European Medicines Agency (EMA) announced on 5 May 2017, during the agency’s third stakeholder event on biosimilars, that it had introduced a new information guide on biosimilars for healthcare professionals.

FDA extends comment period for interchangeability guidance

Home/Guidelines | Posted 24/03/2017

In a Federal Register notice published on 15 March 2017 the US Food and Drug Administration (FDA) announced that it would be extending the comment period on its draft guidance on the interchangeability of biosimilars with their reference biologicals. This change came after the agency received requests for an extension.

FDA recommends minimal design changes for generic drug delivery products

Home/Guidelines | Posted 24/02/2017

The US Food and Drug Administration’s (FDA) latest guidance for industry provides recommendations for manufacturers seeking approval for generic versions of ‘drug-device combination products’, such as auto injectors.

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].

Naming requirements in Australian biosimilars guidance

Home/Guidelines | Posted 04/10/2013

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on naming conventions for biosimilars.

Australia issues new biosimilars guidance

Home/Guidelines | Posted 23/08/2013

Australia’s regulatory body, the Therapeutic Goods Administration (TGA) published specific guidance for biosimilars on its website on 30 July 2013.

Development and regulation of biosimilars in Japan

Home/Guidelines | Posted 16/08/2013

In Japan, a biosimilar product is defined as a biotechnological drug product developed by a different company that is comparable to the approved biotechnology-derived product (reference product) of an innovator company [1, 2].

South Korean guidelines for biosimilars

Home/Guidelines | Posted 09/03/2012

Last update: 10 April 2015

The regulatory body for approval of medicines in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration. The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the South Korea.

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