Guidelines

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.

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The US Food and Drug Administration (FDA) announced on 29 August 2016 that it had released a new draft guidance document for generics of fidaxomicin.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

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the most appropriate methodology for developing drugs, the US Food and Drug Administration (FDA) has released 19 new draft guidance documents and 19 revisions to guidance documents.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.