Regulation and Approval
The European Medicines Agency (EMA) led the way internationally in 2004 by introducing a new EU-wide regulatory pathway, together with product-specific guidelines. The EU centralized approval procedure parallels that for reference biologics. In 2010, the EMA also introduced draft guidelines for biosimilar monoclonal antibodies.Other key markets including the US have now introduced comparable legislation, and Sandoz has led the introduction of biosimilars in countries from Canada to Japan. The US legislation even goes a step further than the EU, offering the potential for full biosimilar interchangeability. However, it also includes an unprecedented patent-related provision that could require biosimilar developers to provide their full dossier to the originator, resulting in potentially lengthy and expensive litigation.
The science underlying evaluation of biosimilars is the same as that used for changes in reference product biologics when their manufacturers scale up processes or shift production lines. As all biologics exhibit batch-to-batch variability within accepted parameters, regulators use the ICH Comparability Guidelines (established in 1996) to harmonize their approach to such changes. The “highly similar” comparability standard used by the US FDA has now been translated into the US biosimilars legislation.
