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FDA releases 37 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 The agency announced on 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.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

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).

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The US Food and Drug Administration (FDA) received 52 comments on its draft guidance on the interchangeability of biosimilars with their reference biologicals.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

Apotex petitions FDA over Neulasta biosimilars

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

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

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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