EGA Biosimilars: European monitoring and global business opportunities

The spotlight was on the European uptake of biosimilars at the European Generic medicines Association’s (EGA) 12th annual conference on biosimilar medicines in London last week. In one of the opening addresses, Salvatore D’Acunto, head of food and healthcare industries, Biotechnology, Enterprise and Industry Directorate-General of the European Commission, spoke to delegates about the EC’s policy strategy on biosimilars.

Regulatory strategy

He said the EC’s biosimilars project group aims to define the necessary conditions for an informed uptake and adequate patient access to biosimilar medicinal products. This includes working on final projects including an overview of information on reimbursement status of biosimilar medicinal products in EEA countries, an IMS study on ‘Biosimilar accessible market: Size and biosimilar penetration’ and the information document ‘What you need to know about Biosimilar Medicinal Products’. This document aims to provide information about treatment options provided by biosimilars in order to make physicians aware of the potential for gains. He clarified that the EC had no role in the interchangeability, substation or switching policies for biosimilars. The main message of the paper is how the availability of biosimilar medicinal products can enhance competition, improve patient access to biological medicines and contribute to the financial sustainability of EU healthcare systems.