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FDA releases 67 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 a whole host of new bioequivalence documents. The agency announced on 1 October 2016 that it had released 34 new draft guidance documents and 33 revisions to guidance documents on bioequivalence requirements for the development of generics containing 59 different active ingredients.

FDA issues guidance on self-identification for generics makers

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

ACR asked for guidelines on biosimilar substitution

At the US Food and Drug Administration’s (FDA) latest meeting on Biosimilar User Fee Act Reauthorization (BsUFA II), the American College of Rheumatology (ACR) asked FDA to create guidelines for biosimilar substitution.

Japanese guidelines for biosimilars

Last update: 21 October 2016

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.

US guidelines for biosimilars

Last update: 21 October 2016

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

Biosimilars interchangeability guidance expected by end 2017

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.

Australia to adopt EMA generics guidelines

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.

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The US Food and Drug Administration (FDA) announced on 29 August 2016 that it had released a new draft guidance document for generics of fidaxomicin.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

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