Guidelines

Stakeholders comment on FDA’s draft statistical biosimilarity guidance

Home/Guidelines | Posted 08/12/2017

The US Food and Drug Administration (FDA) released draft guidance on statistical approaches to evaluate similarity for biosimilars in September 2017 [1]. Comments from stakeholders on the guidance indicate that they want it to be more specific and narrower in scope.

FDA publishes new draft guidance for ADHD generic

Home/Guidelines | Posted 24/11/2017

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

India updates its similar biologics guidelines

Home/Guidelines | Posted 10/11/2017

The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars. The update was seen as essential in order to meet the ‘ever changing global standards’.

FDA releases 52 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 03/11/2017

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 The agency announced on 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.

New guidelines expected to encourage generics in China

Home/Guidelines | Posted 27/10/2017

New guidelines have been finalized in China to try and make the country a more drug-friendly market, while also promising progress in the use of generics.

FDA draft guidance clarifies when a 505(b)2 application can be submitted

Home/Guidelines | Posted 20/10/2017

The US Food and Drug Administration (FDA) has issued new draft guidance intended to help companies determine whether to submit an abbreviated new drug application (ANDA), i.e. 505(j), or a 505(b)(2) application.

Canadian guidelines for biosimilars

Home/Guidelines | Posted 29/10/2010

Last update: 20 October 2017

The regulatory body for approval of biologicals in Canada is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars

Home/Guidelines | Posted 29/09/2017

The US Food and Drug Administration (FDA) has released draft guidance, which the agency says, when finalized, will provide advice on the evaluation of analytical similarity for biosimilars.

New EMA reflection paper on setting dissolution specifications

Home/Guidelines | Posted 08/09/2017

The European Medicines Agency (EMA) released a reflection paper on 15 August 2017 which will help generic drugmakers to set specifications for the in vitro dissolution of immediate-release oral drugs.

New FDA guidance on biological manufacturing changes

Home/Guidelines | Posted 25/08/2017

The US Food and Drug Administration (FDA) has released draft guidance on post-approval manufacturing changes for biological products, which outlines which changes have the least potential to affect product quality and how to document them in an annual report.