EGA Press Release

Monday, 3 September 2007

EGA WELCOMES APPROVAL OF FIRST BIOSIMILAR EPOETIN

The EGA welcomes the European Commission’s Decision approving for the first time a biosimilar epoetin alfa to be marketed under the names Binocrit, from Sandoz GmbH, Abseamed, from Hexal Medice Arzneimittel Pütter GmbH&Co, and Epoetin alfa Hexal, from Hexal Biotech Forschungs GmbH. These new biosimilar medicines, based on one development, have been shown to match a previously approved reference product in terms of quality, safety and efficacy and have received marketing authorisation for treating anaemia in patients suffering from chronic renal deficiency, and in oncology patients.

The Commission’s Decision follows on from the positive scientific opinion issued in June by their scientific body, the European Medicines Agency‘s Committee for Medicinal Products for Human Use (CHMP).

“These approvals definitely clarify for our industry the issue of assigning International Non-proprietary Names (INN) for biosimilar medicines”, said Suzette Kox, EGA Senior Director Scientific Affairs. The newly approved biosimilar products do contain the active substance ‘epoetin alfa’ as their respective reference product with which they were compared extensively. “Following upon the international debate regarding the allocation of INNs to biosimilar medicines and the major challenges imposed on our industry in this regard, we are very pleased that the EGA’s often reiterated expectation that only scientific considerations should be taken into account for allocation of INNs have been met”, Ms. Kox added.

Moreover, Ms Kox welcomed these important EU approvals as further evidence that the necessary science and technology are indeed available to develop biosimilar medicines of larger, more complex protein molecules. “The EU epoetin approval constitutes a further breakthrough in the global history of the development of biosimilar biotechnological medicines”, Ms Kox said.

The European Commission has now approved five biosimilar medicines (human growth hormone and epoetin) under the scientific guidelines and regulatory procedures laid out in the new EU pharmaceutical legislation, and a number of additional biosimilar medicines’ applications have been received by the EMEA. Following the tradition of affordable generic medicines, which generate estimated annual savings in Europe of some €18-€20 billion, biosimilar medicines are expected to contribute significantly to reducing the price of healthcare in the EU.

According to EGA Director General Greg Perry, “Competitively priced, high quality biosimilar medicines will soon become a necessary component of future healthcare management policies, as even a 20% price reduction on just six off-patent biopharmaceutical products would save the EU some €1.6 billion each year.”

“Now”, Mr Perry insists, “it is time to focus attention fully on building a reliable ‘market pathway’ for biosimilar medicines, and on raising awareness among clinicians and pharmacists in order to improve the availability of these medicines to more patients.”

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