Guidelines
India updates its similar biologics guidelines
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
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 The agency announced on 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.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
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FDA draft guidance clarifies when a 505(b)2 application can be submitted
The US Food and Drug Administration (FDA) has issued new draft guidance intended to help companies determine whether to submit an abbreviated new drug application (ANDA), i.e. 505(j), or a 505(b)(2) application.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FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars
The US Food and Drug Administration (FDA) has released draft guidance, which the agency says, when finalized, will provide advice on the evaluation of analytical similarity for biosimilars.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The US Food and Drug Administration (FDA) has released draft guidance on post-approval manufacturing changes for biological products, which outlines which changes have the least potential to affect product quality and how to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].
