EuropaBio sets out views on biosimilars, saying they should not be treated like generics

To contribute to an informed debate, the biotech trade group EuropaBio is launching a new brochure acknowledging the complexity of biotechnology-derived medicines (which are also referred to as biological medicines) and the emergence in Europe of a new category of biotech medicines: biosimilars.

Following the definition of the European Medicines Agency and the establishment of a regulatory approval pathway, EuropaBio believes that, due to the unique nature of biological medicines and biosimilars, the latter should not be treated in the same way as a generic of a chemical medicine.

Since introducing the concept of biosimilars in its legislation in 2004, the European Union has been at the forefront of the development of a strong science-based regulatory pathway for biosimilars, providing patients with the assurance that these products are safe and successful. In the context of global economic and financial constraints, biosimilars may have an important role to play in fostering competition in the market place and thereby contributing to the sustainability of healthcare budgets and securing the necessary funds to pay for further innovation.