EGA Press Release

Friday, 9 December 2005

BIOSIMILAR MEDICINES: TIME TO DELIVER

Speaking today at a press conference organised in Paris by the EGA during the EMEA Workshop on biosimilar medicines, Greg Perry, Director General of EGA announced that “The current level of biological science and recently enacted pharmaceutical legislation in Europe mean that the next generation of affordable medicines is no longer a distant dream, but rather a soon to be realised reality.”

Mr Perry went on to explain that Europe’s biosimilar companies have the scientific expertise and the technical experience to produce safe and effective follow-on pharmaceuticals based on medicines derived from biotechnology. As of November 2005, the European Medicines Agency (EMEA) is endowed with the proper legislative framework to competently evaluate the quality and safety of these new biological medicines. And Europe’s healthcare systems are more than ready for the cost relief these new products will bring in addition to increased patient access to life enhancing treatments.

According to Tim Oldham, chair of the EGA Biotechnology and Biosimilars Committee, the first wave of biosimilars, comprised of only six products, will generate savings of around €2 billion per year. “This amount”, he says, “would allow an additional 500,000 people suffering from kidney failure to receive EPO treatments, thus prolonging the time before they need dialysis.” Originator biologicals currently account for seven of the top ten injectable medicines, providing treatment for conditions ranging from diabetes to renal deficiency. The annual cost of these originator medicines range from €10,000 to €100,000 per person. Experience with biosimilars in non-EU countries indicates that they sell at 25% to 40% below the prices of originator products.

In addition, with Europe’s current level of preparedness, the EU is now poised to become the global centre for research, development and production of this new generation of affordable, biotech pharmaceuticals, giving the EU a huge competitive advantage over other countries like the United States and Japan. Developing the biosimilar industry will create numerous new research jobs in Europe and will make a major contribution to meeting the EU’s Lisbon agenda on competitiveness in the EU pharmaceutical sector.

For all of this to indeed become a reality, Mr Oldham explained, “the implementation of the EU guidelines governing biosimilar R&D must continue along the solid science-based agenda laid out in the new EU medicines legislation. And it must bear fully in mind the known characteristics of these products and the public health benefits at stake.” To fully realise these health benefits, further action is needed at the EU and Member State level to ensure timely and efficient access to these more affordable biological products. The measures required include ensuring the substitutability and interchangeability of these medicines while applying the established risk management framework pragmatically and sensibly, consistent with the EU pharmaceutical reform to streamline pricing and reimbursement systems across Europe.

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