EMA: Concept paper on the revision of the guideline on similar biological medicinal product – draft (consultation open)

The so-called “overarching” guideline on similar biological (biosimilar) medicinal products CHMP/437/04 was discussed in CHMP in 2004 and, after external consultation, came into force in 2005. Reference to this guideline is implicit in the legislation where it is stated in Section 4, Part II, Annex I to Directive 2001/83/EC that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’. Since 2005, the CHMP has seen numerous Scientific Advice procedures and Marketing Authorisation Applications, and several biosimilars have already been marketed. Thus, considerable experience has been gained on the concept of biosimilarity not only from a conceptual but also from a data perspective.