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Application V15a16

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’.

Guidance V13F21

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15 March 2017 the US Food and Drug Administration (FDA) announced that it would be extending the comment period on its draft guidance on the interchangeability of biosimilars with their reference biologicals.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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FDA recommends minimal design changes for generic drug delivery products

Home/Guidelines | Posted 24/02/2017

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

Home/Guidelines | Posted 17/02/2017

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.

Guidance V13F21

New FDA guidance to speed up generics approvals

Home/Guidelines | Posted 10/02/2017

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. 

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FDA issues final guidance on naming biologicals

Home/Guidelines | Posted 27/01/2017

The US Food and Drug Administration (FDA) has issued final guidance detailing the agency’s requirements for the non-proprietary naming of biological products.

Substitution V13F14

FDA issues draft guidance on biosimilar interchangeability

Home/Guidelines | Posted 20/01/2017

The US Food and Drug Administration (FDA) has finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals.

Pharmacology MIT

FDA issues final guidance on pharmacology data for biosimilarity

Home/Guidelines | Posted 13/01/2017

The US Food and Drug Administration (FDA) on 29 December 2016 published final guidance outlining the clinical pharmacology data necessary to support a biosimilar application.

Biosimilars V13E10

Biosimilars interchangeability guidance expected by end 2017

Home/Guidelines | Posted 14/10/2016

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.