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EMA releases product-specific bioequivalence guidelines

The European Medicines Agency (EMA) announced on 15 November 2013 the release of the agency’s first product-specific guidance on the demonstration of bioequivalence for 16 active substances. The draft guidelines have been released for a three-month public consultation period.

EU guidelines for nanosimilars

Last update:  5 November 2013 

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.

Brazilian guidelines for follow-on biological products

Last update: 31 October 2013

The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which was created by Law 9782, enacted in 1999. ANVISA is responsible, under the authority of the Ministry of Health–Mínistério de Saúde–of the Brazilian Government, for drug registration and licences to pharmaceutical laboratories and to other companies inside the pharmaceutical production flow. The agency is also responsible for establishing regulations applicable to clinical trials and drug pricing, which is carried out by the Chamber of Drug Market Regulation.

EMA issues draft reflection paper for iron-based nano-colloidal products

On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper to discuss the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicine. The draft reflection paper has been released for a five-month consultation period.

Naming requirements in Australian biosimilars guidance

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on naming conventions for biosimilars.

FDA publishes guidance on ANDAs for new strengths

The US Food and Drug Administration (FDA) has published draft guidance for industry for abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) where the applicant is seeking approval of a new strength of the drug product.

EMA organizes workshop on biosimilars guidelines

The European Medicines Agency (EMA) announced on 25 September 2013 that the agency would be organizing a workshop on biosimilars.

Australia issues new biosimilars guidance

Australia’s regulatory body, the Therapeutic Goods Administration (TGA) published specific guidance for biosimilars on its website on 30 July 2013.

Development and regulation of biosimilars in Japan

In Japan, a biosimilar product is defined as a biotechnological drug product developed by a different company that is comparable to the approved biotechnology-derived product (reference product) of an innovator company [1, 2].

EMA issues draft concept paper on comparing quality in biologicals and biosimilars

On 28 June 2013, the European Medicines Agency (EMA) released a draft concept paper to discuss the issue of how to compare the quality attributes for biological products and biosimilars. The draft concept paper has been released for a three-month consultation period.

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