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FDA releases new bioequivalence guideline for fidaxomin generics

The US Food and Drug Administration (FDA) announced on 29 August 2016 that it had released a new draft guidance document for generics of fidaxomicin.

FDA on interchangeability and demonstrating biosimilarity

The US Food and Drug Administration (FDA) intends to clarify its expectations for demonstrating the interchangeability of biosimilars with their reference biologicals, according to Dr Steven Kozlowski, Director of the Office of Biotechnology Products at FDA.

IPRF issues draft reflection paper for biosimilars extrapolation

The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) announced on 6 September 2016 that it had released a draft reflection paper on the extrapolation of indications in the authorization of biosimilars.

EMA adopts new guidance on monitoring of biologicals

The European Medicines Agency (EMA) announced on 15 August 2016 that it had introduced a new guideline on the monitoring of biologicals, including biosimilars.

Europe to revise drug similarity concept under orphan legislation

The European Commission announced on 27 July 2016 a proposal to review the concept of ‘similar medicinal products’ in the context of the orphan legislation.

FDA withdraws biosimilar suffix proposal

The US Food and Drug Administration (FDA) has announced that it is withdrawing a request for comments on expanding the number of suffixes biosimilars makers can propose.

FDA asks for input on product-specific generics guidelines

In order to further facilitate the availability of generics and to assist the generics industry with identifying the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.

Biosimilarity statement unnecessary according to industry

Industry groups have expressed concerns about the proposal for a biosimilarity statement in the US Food and Drug Administration’s (FDA) draft guidance on biosimilar labelling.

US guidelines for biosimilars

Last update: 17 June 2016

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

FDA increases number of biological suffix proposals

The US Food and Drug Administration (FDA) has announced a slight change to its guidance on naming biologicals, which will allow companies to propose up to 10 suffixes for each new biological or biosimilar. The agency announced the change in a Federal Register notice released on 2 June 2016.

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