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EMA finalises biosimilar monoclonal antibody guidelines

EMA announced on 15 June 2012 that it had finalised two guidance documents describing how pharmaceutical companies should develop biosimilar monoclonal antibodies. The guidelines set out how developers should conduct extensive side-by-side analysis of the test and reference products in order to determine similarities and potential differences between the biosimilar and reference biological.

Guidelines for substitution of generics in The Netherlands

Marketed medicines that have passed bioequivalence testing should in general be substitutable. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generics substitution. The generics substitution guidelines are based on scientific principles and provide a strong impetus for maintaining uniform professional standards.

EMA revised guideline on quality of biosimilar medicines open for comments

EMA announced on 31 May 2012 that it had released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines.

Mexican biocomparables guidelines come into force

The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) announced on 20 April 2012 that the Mexican guidelines for biocomparables had come into force.

Turkish guidelines for generics

Last update: 4 May 2012 

The regulatory body for approval of pharmaceutical products in Turkey is the General Directorate of Pharmaceuticals and Pharmacy (GDPP).

EMA released pharmacovigilance guidelines for public consultation

EMA has released its first batch of guidelines on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.

Australian government urged not to make further cuts to PBS

In the wake of historically the largest single price cuts to prescription medicines in Australia, both Medicines Australia and the Generic Medicines Industry Association of Australia (GMiA) are urging the government that further cuts to the Pharmaceutical Benefits Scheme (PBS) are not justified.

Global guidelines for generic medicines

Last updated: 23 April 2012

The public health arm of the United Nations is World Health Organisation (WHO).

WHO provides guidelines in the area of quality assurance of pharmaceutical products. These guidelines are established and maintained through a consultative procedure and adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are submitted to the WHO’s governing bodies for endorsement and subsequent implementation by Member States.

FDA issues drug shortage draft guidance

FDA announced on 21 February 2012 the release of drug shortage draft guidance for industry in order to increase the supply of critically needed cancer drugs. The announcement follows an Executive Order signed by US President Barack Obama in October 2011 in an attempt to resolve escalating shortages of life-saving medicines [1].

Interchangeability not covered in FDA draft biosimilar guidance

FDA has finally issued draft guidance documents for biosimilars. However, the guidelines still do not address the issue of interchangeability of originator drugs and biosimilars.