Building trust in biosimilars main challenge of EGA

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So far, three types of biosimilar medicines have been approved in the EU – somatropin (human growth hormone, hGH), epoetin (erythropoietin, EPO) and filgrastim (granulocyte colony-stimulating factor, G-CSF)) – in the form of 13 marketing authorisations from various companies under many different names.

The six “biosimilar developments” that gained EU approval are somatropin of Sandoz (Omnitrope, April 2006), somatropin of BioPartners (Valtropin, April 2006), epoetin alfa of Sandoz, Hexal and Medice (Binocrit/Epoetin alfa Hexal/Abseamed, August 2007), epoetin zeta of Hospira and Stada (Silapo/ Epoetin Retacrit, December 2007), filgrastim of Teva, Ratiopharm and CT Arzneimittel (Tevagrastim/ Filgrastim Ratiopharm/Biograstim, September 2008), and filgrastim of Hexal and Sandoz (Filgrastim Hexal/Zarzio, February 2009).

However, these cheaper versions of off-patent biologicals are not yet prescribed as often as hoped by the European Generic medicines Association (EGA). “Promoting the use of biosimilar medicines is vital to increasing patient access to life-saving medicinal care and to ensuring the sustainability of EU healthcare systems,” claimed EGA Director-General Mr Greg Perry at the 7th EGA Symposium on Biosimilar Medicines recently held in London. “Building trust in them among payers and practitioners is of the utmost importance.” Furthermore, EGA will deal with any ‘misinformation’ on biosimilars possibly spread by originators.

Mr Perry said building confidence in the EMEA’s Committee for Medicinal Products for Human Use (CHMP) is essential too by showing its high standards and outstanding level of scientific evaluation. “For example, not every biosimilar application has been approved by the EMEA: three out of nine developments – interferon alfa-2a, interferon beta-1a and human insulin – were rejected or withdrawn during the evaluation process.”

He observed a positive trend in applications for marketing authorizations for biosimilars. “In 2009 the EMEA expects eight new applications, some of which have already been received. Interest in biosimilars has been increasing, and the products are making inroads into the market, particularly in Germany, where all somatropins are now in the same reference price group.”

Professor Colin Brown, a Consultant Renal Physician, stressed that most clinicians do not want to know much about new medicines: only that they are as effective and safe as the products they’re using. “Firms such as Teva should send their scientists to international conferences to explain the science behind biosimilars and show under what conditions they can safely be used. Then physicians and patient groups will listen and get interested in using biosimilars,” he suggested.

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