The European Medicines Agency has updated its guidance for pharmaceutical companies on biosimilar medicines to reflect the European Commission's confirmation that it intends to accept batches of reference medicines sourced from outside the European Economic Area (EEA) in the future. This aims to facilitate the global development of biosimilars and avoid the unnecessary repetition of clinical trials.
Under the current European legal framework, companies developing a biosimilar medicine are required to identify a reference medicine that is or has been authorised in the EEA and whose batches are sourced from within the EEA. With the new approach, first announced by Commissioner John Dalli in Malta on 15 June 2012, the Agency will begin to accept reference medicine batches sourced from outside the EEA in certain pre-clinical and clinical studies in the comparability exercise.
Applicants will be responsible for establishing that batches sourced from outside the EEA are representative of the reference medicine authorised in the EEA through an extensive analytical comparison. Applicants may need to supply comparative pharmacokinetic and pharmacodynamic data to ascertain the suitability of batches of the reference medicines. These changes will come into effect after the revision of the guideline on similar biological medicinal products. The Agency expects to release a draft version of this revised guideline for public consultation in early 2013. The Agency has also updated its question-and-answer document on biosimilars for the public today, in response to comments from stakeholders, including patients, healthcare professionals and the pharmaceutical industry.
The update, which was carried out in consultation with the experts from the Agency’s Biosimilar Medicinal Products Working Party (BMWP), includes more information on biological medicines in general, a statement that biosimilar medicines are not the same as generic medicines, information on the evaluation of possible differences between biosimilar medicines and their reference medicines and information on interchangeability.
A similar biological or 'biosimilar' medicine is a biological medicine that is similar to another biological medicine that has already been authorised for use, called the reference medicine. Biological medicines are medicines that are made by or derived from a biological source. They can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies.
The updated information for applicants can be found in question 4 of the questions and answers on similar-biological-product applications.
<http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000529.jsp&mid=WC0b01ac0580533e0b> Questions and answers: Similar-biological-product applications <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf> EMA Procedural advice for users of the Centralised Procedure for Similar Biological Medicinal Products applications <http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000157.jsp&mid=WC0b01ac058002251f> European Medicines Agency - Pre-authorisation - Presubmission guidance: questions and answers
<http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000157.jsp&mid=WC0b01ac058002251f> European Medicines Agency - Pre-authorisation - Presubmission guidance: questions and answers
This section of the website contains questions that marketing-authorisation holders (MAHs) may have related to presubmission guidance for innovative medicines. <http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000157.jsp&mid=WC0b01ac058002251f> View on www.ema.europa.eu