Europe was a pioneer in establishing a legal framework and regulations for the approval of biosimilar medicines. At present, there are 19 biosimilars authorized by the European Commission (CE) and six products under evaluation by the European Medicines Agency (EMA), which could lead to new authorizations, all together with numerous biosimilar candidates in investigation.
In addition, two biosimilar candidates, one for rheumatoid arthritis and other inflammatory diseases and another for diabetes have received in November 2015 the positive opinion of the EMA and will presumably be added shortly to the list of EC authorized biosimilars.
Since in 2003 the concept of “similar biological medicinal product” in European legislation, the EMA together with the Committee for Medicinal Products for Human Use (CHMP) have worked on specific guidelines to address all aspects of biosimilar development, production, testing and regulation.
The first regulations made public by the EMA between 2005 and 2006 included a main guideline (overarching) and others about quality, and both clinical and non-clinical aspects. However, there are also product-specific recommendations detailing the requirements on a case-by-case basis, for example for insulin, somatropin, EPO or monoclonal antibodies. Among many other properties, as for any original biological, the possible immunogenicity of biosimilars.
However, it must be taken into account that these regulations evolve over time, incorporating scientific and technological developments and the experience accumulated with marketing authorization applications.