EMA: Draft guideline on similar biological medicinal products

This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive 2001/83/EC, as amended, where it is stated 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’.