Article originally published in the Life Sciences Handbook Cross-border in 2011 

During the past ten years, many stakeholders have expressed an interest in the availability of biologically derived medicines authorised on the basis of previously authorised biological refer­ence products, that is, on the basis of a truncated dossier that includes a robust showing of similarity between the two products. These medicines are known as biosimilars in many parts of the world, including Europe and now the US. In other jurisdictions, they may have different labels. (Under Canadian law, for exam­ple, they are known as subsequent entry biologics.) An increasing number of countries have passed laws, implemented regulations, or developed regulatory guidelines to govern the authorisation of biosimilars, and many have begun authorising them. For exam­ple, as of January 2011, biosimilar human growth hormone has been authorised in Canada, the US, Australia, and Europe, and indeed the European Commission has authorised 14 biosimilars. Regulation of biosimilars is evolving rapidly, because of:

  • Increasing pressure for lower cost versions of biological medicines.
  • Scientific technology (particularly analytical technology) continuing to improve.
  • Regulators and stakeholders gaining experience with these complex molecules and the issues they present.

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.