Guidelines

FDA draft guidance clarifies when a 505(b)2 application can be submitted

The US Food and Drug Administration (FDA) has issued new draft guidance intended to help companies determine whether to submit an abbreviated new drug application (ANDA), i.e. 505(j), or a 505(b)(2) application.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

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FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars

The US Food and Drug Administration (FDA) has released draft guidance, which the agency says, when finalized, will provide advice on the evaluation of analytical similarity for biosimilars.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

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

The US Food and Drug Administration (FDA) has released draft guidance on post-approval manufacturing changes for biological products, which outlines which changes have the least potential to affect product quality and how to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

The US Food and Drug Administration (FDA) received 52 comments on its draft guidance on the interchangeability of biosimilars with their reference biologicals.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

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

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

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

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].