The European Medicines Agency (EMA) published draft guidelines today, 2nd May 2013 on Similar Biological Medicinal Products. The 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’. The draft guidance is open to consultation until the 31st October 2013.
Newly Published Draft Guideline on Similar Biological Medicinal Products
Pharma IQ | 05/01/2013