Guidelines

FDA publishes new draft guidance for ADHD generic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In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.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 The agency announced on 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.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FDA draft guidance clarifies when a 505(b)2 application can be submitted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The US Food and Drug Administration (FDA) has issued new draft guidance intended to help companies determine whether to submit an abbreviated new drug application (ANDA), i.e. 505(j), or a 505(b)(2) application.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FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars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The US Food and Drug Administration (FDA) has released draft guidance, which the agency says, when finalized, will provide advice on the evaluation of analytical similarity for biosimilars.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.

Physician associations comment on FDA’s interchangeability guidance

Home/Guidelines | Posted 30/06/2017

The US Food and Drug Administration (FDA) received 52 comments on its draft guidance on the interchangeability of biosimilars with their reference biologicals.

Comments on switching in FDA’s interchangeability guidance from big pharma

Home/Guidelines | Posted 23/06/2017

The US Food and Drug Administration’s (FDA) comment period on its guidance on the interchangeability of biosimilars with their reference biologicals ended on 19 May 2017 [1].

Comments on extrapolation in FDA’s interchangeability guidance from big pharma

Home/Guidelines | Posted 16/06/2017

19 May 2017 marked the end of the comment period on the US Food and Drug Administration’s (FDA) guidance on the interchangeability of biosimilars with their reference biologicals [1].

Big Pharma comments on FDA’s interchangeability guidance

Home/Guidelines | Posted 09/06/2017

The comment period on the US Food and Drug Administration’s (FDA) guidance on the interchangeability of biosimilars with their reference biologicals ended on 19 May 2017 [1].

Comments on FDA’s interchangeability guidance

Home/Guidelines | Posted 02/06/2017

The US Food and Drug Administration (FDA) finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals in January 2017 [1]. FDA initially released the document for a 60-day comment period (until 20 March 2017), but subsequently extended the period until 19 May 2017 [2].

FDA to speed up review of priority generics

Home/Guidelines | Posted 18/08/2017

As part of the Generic Drug User Fee Amendments Reauthorization (GDUFA II) recently agreed with industry [1], the US Food and Drug Administration (FDA or Agency) has released guidance outlining how sponsors can qualify for shorter review times for priority generics.

EMA adopts five product-specific bioequivalence guidelines

Home/Guidelines | Posted 11/08/2017

The European Medicines Agency (EMA) has adopted five product-specific guidance documents on the demonstration of bioequivalence. The guidelines were published on 10 July 2017 and will become effective from 1 January 2018.

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.

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