Guidelines
FDA to speed up review of priority generics
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
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
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 The agency announced on 15 May 2017 that it had released 21 new draft guidance documents and 16 revisions to guidance documents on bioequivalence requirements for the development of generics containing 33 different active ingredients.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).
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.
FDA recommends minimal design changes for generic drug delivery products
The US Food and Drug Administration’s (FDA) latest guidance for industry provides recommendations for manufacturers seeking approval for generic versions of ‘drug-device combination products’, such as auto injectors.
FDA rejects petitions over biologicals naming guideline
The US Food and Drug Administration (FDA) has rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same non-proprietary names as their reference products.
New FDA guidance to speed up generics approvals
Updated guidance released by the US Food and Drug Administration (FDA) renews the criteria for receiving generic drug applications and downgrades certain deficiencies to ease the pressure on industry.
