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Call for action on labelling of biosimilars

European trade association, the European Association for Bioindustry (EuropaBio) has called on the European Medicines Agency (EMA) to define specific guidance on the labelling of biosimilars.

Biosimilars applications under review by EMA – August 2014

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

‘Similar biologics’ approved and marketed in India

Last update: 26 September 2014

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].

Biosimilars of trastuzumab

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Biosimilars approved in South Korea

Last update: 19 September 2014

In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.

Similar biotherapeutic products approved and marketed in Latin America

Last update: 19 September 2014

Regulation of similar biotherapeutic products in Latin America varies widely among different countries and many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].

FDA debuts purple book for biologicals and interchangeable biosimilars

On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Purple Book’, a new set of lists of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generic equivalents.

US senators call for guidance on biosimilars

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to release guidance on key scientific policy questions related to biosimilars.

Physicians believe biosimilars should have different names

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

WHO proposal offers clarity for biosimilar nomenclature

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized naming scheme for biological products, including biosimilars. According to the proposal, a four-letter code – the BQ – would be added after the INN.

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