On 15 November 2013, the EMA released the first draft product-specific guidance documents on the demonstration of bioequivalence for 16 active substances for public consultation.

This first set of guidance builds upon the general principles set out in the Agency’s Guideline on the investigation of bioequivalence of 2010, which specified the requirements for the design, conduct and evaluation of bioequivalence studies for immediate release dosage forms with systemic action.  These first guidance documents will be followed by another wave of product-specific guidance in the course of 2014.

The 16 substances concerned are the following:

  •  capecitabine;
  • carglumic acid;
  • dasatinib;
  • emtricitabine/tenofovir disoproxil;
  • erlotinib;
  • imatinib;
  • memantine;
  • miglustat;
  • oseltamivir;
  • posaconazole;
  • repaglinide;
  • sirolimus;
  • sorafenib;
  • tadalafil;
  • telithromycin;
  • voriconazole.

 Two medicinal products are considered bioequivalent if they release the same active ingredient into the human body at essentially the same rate and to the same extent under similar conditions.  Bioequivalence is an important factor to be considered in applications for generic medicinal products according to Article 10(1) of Directive 2001/83/EC.  Demonstration of bioequivalence may also be required to support other types of applications such as variations to marketing authorisations, fixed-dose combinations, extensions of indications or so-called hybrid applications.

The EMA intends to provide through this product-specific guidance a consistent approach to the assessment of applications based on bioequivalence data and more efficient guidance for future applications.  The guidance concerns all authorisation routes available in the EU, namely the centralised, decentralised, mutual recognition and national marketing authorisation procedures.

Guidance is provided according to:

  • biopharmaceutical classification system (BCS);
  • type of bioequivalence study design;
  • analyte (parent drug or metabolite) to be evaluated;
  • bioequivalence assessment.

Interested parties may submit their comments on the guidance documents to pkwpsecretariat@ema.europa.eu, using the available submission forms, until the 15 February 2014.

Originator companies that developed products containing any of these active ingredients are particularly well placed to submit comments.