EGA Press Release

Thursday, 3 May 2007

BUILDING A “MARKET PATHWAY” FOR BIOSIMILAR MEDICINES

In his presentation at the 5th EGA Symposium on Biosimilar Medicines on Friday in London, Greg Perry, Director General of EGA, said “Now that the science and the regulatory pathway have been established in the EU, industry and regulators must focus on building a ‘market pathway’ for biosimilar medicines”.

Mr Perry described the future role of biosimilar medicines in Europe as a continuation of the tradition established by generic medicines over the past two decades, reminding his audience that generic medicines account for nearly 50% of medicines in the EU-27 today, generating savings of €18-20 billion.

Building on this legacy of savings and market efficiency, Mr Perry said, biosimilar medicines can be seen as an “economic innovation”. By 2010, highly expensive biopharmaceutical products will make up 25% of pharmaceutical sales and 50% of all new applications. As a result, biosimilar medicinal products will soon become a necessary component of future healthcare management policies, as even a 20% price reduction on six off-patent biopharmaceutical products would save the EU some €1.6 billion each year.

In this regard, Mr Perry said, the progress in biosimilars is encouraging but that certain issues needed urgent attention.

The European Medicines Agency (EMEA) approved the first two biosimilar products in the EU and began reviewing three more applications in 2006. The EMEA now reports receiving seven additional applications as of April this year, and that a total of 12 applications are expected for 2007.

Therefore, Mr Perry said it is now time to focus attention on building a “market pathway” to ensure that these new, more affordable products become available to patients quickly. Increasing the confidence of patients and healthcare professionals in biosimilar medicines is key to developing this pathway. “However”, Mr Perry announced, “we are seeing a re-run of the arguments originally put forward against the entry of generic medicines nearly 20 years ago.”

Mr Perry reminded his audience that, contrary to the misinformation often heard, biosimilar products must be proven to be as safe and effective as the reference product (RP); they must be rigorously evaluated for similarity and comparability with the RP; companies must use the latest analytical and clinical technologies available, often including some not originally available to assess the RP; and a strategy for post-marketing monitoring must be developed to assure continued safety and efficacy.

With this in mind, Mr Perry urged the following measures to create an effective market pathway for biosimilar products:

• Acknowledgement of the interchangeability of biosimilar products,
• Maintenance of the current scientific approach to INN naming, and
• Pricing structures designed to foster biosimilar market entry and competition.

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