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EMA issues revised version of biosimilars quality guideline

On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of similar biological medicinal products. The guideline will come into effect by the end of the year.

EU guidelines for biosimilars

Last update: 4 July 2014

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

Draft guide on monitoring medical literature released for public consultation

On 5 June 2014, the European Medicines Agency (EMA) released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database. The draft guideline has been released for a two-month public consultation period.

Brazil speeds up approval process for generics and biologicals

Brazil’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA] announced on 3 June 2014 the publication of a new guideline for generics and biologicals aimed at speeding up the regulatory procedure.

EMA issues draft guideline for insulin biosimilars

On 30 April 2014 the European Medicines Agency (EMA) released a draft guideline on the non-clinical and clinical development of insulin biosimilars. The draft guideline has been released for a three-month consultation period.

FDA releases further biosimilars guidance

The US Food and Drug Administration (FDA) has issued new draft guidance for biosimilars. The draft guideline, issued in May 2014, explains how to use clinical pharmacology data to show biosimilarity to a reference product.

Iranian guidelines for ‘biogenerics’

The regulatory body for approval of medicines in Iran is the Ministry of Health and Medical Education through its Food and Drug Organization (FDO). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Iran.

US guidelines for biosimilars

Last update: 16 May 2014

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

Australian guidelines for biosimilars

Last update:  25 April 2014

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

FDA releases bioequivalence guidance for 26 generics

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question.

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