Paul Declerck: “Overall, the approach for approval of true biosimilars is quite consistent. However, one may observe differences in subdomains, depending on the evaluator or depending on the ‘habits’. For example, the European Medicines Agency may look at extrapolation slightly differently relative to Health Canada. Another important difference is the attitude towards ‘interchangeability’. In line with the fact that interchangeability refers to the property of the drug, the FDA clearly requires scientific data that provides evidence for interchangeability of a biosimilar with its respective reference product. Therefore in the US, a biosimilar cannot be considered interchangeable unless this is proven. In Europe, the European Medicines Agency does not take a particular ‘position’ regarding interchangeability of biosimilars since this is a matter that legally belongs to the member states.”
Fernando de Mora: “Europe was the first region in the world to set a science-based, stringent guidance for industry to develop biosimilars. Other regions have followed on the basis of the same scientific principles (Australia, Canada, Japan, US, etc.), but many do still lag behind. This means that regulatory convergence is on the way, but is far from having been reached. Many worldwide biologic products claiming to be biosimilars, would certainly never make it to the European market or to any highly regulated market, because Europe has a far more demanding regulatory framework. Many of those less regulated areas share the same challenges. Importantly, there needs to be a set of guidelines that mirror themselves into the European experience. Regulators need to be trained to be able to assess high quality biosimilar dossiers and authorities need to understand that putting in place such a regulation is for the long-term benefit of patients.”
Arno Kromminga: “In bioanalysis and immunogenicity there is good agreement between the guidelines from FDA and EMA. Minor differences may be addressed and harmonized in the future. The Japanese and other agencies will need to be included as well as guidelines from countries with a strong biosimiliar pipeline.”
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