Reuters: Regulatory News: UPDATE 1-Biosimilar versions of Remicade given EU green light

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UPDATE 1-Biosimilar versions of Remicade given EU green light Jun 28th 2013, 12:52 Fri Jun 28, 2013 8:52am EDT * EMA backs Celltrion's Remsima and Hospira's Inflectra * First recommendation for copycat versions of antibody-based drugs * Biotech medicines harder to copy, need more tests LONDON, June 28 (Reuters) - European regulators have recommended approval of two copycat versions of the blockbuster rheumatoid arthritis drug Remicade, the first time a green light has been given for such antibody-based medicines. The European Medicines Agency (EMA) said on Friday that its experts had backed approval of Remsima, made by South Korea's Celltrion, and Hospira's Inflectra, both of which are so-called biosimilar versions of Johnson & Johnson and Merck & Co's injectable drug Both of the biosimilars have been recommended for a range of auto-immune diseases including rheumatoid arthritis, Crohn's disease and psoriasis among others. Celltrion President Seo Jung-jin, who has put his controlling stake in Celltrion up for sale, said in April that European approval of the company's product was imminent. Hospira has a distribution deal for biogeneric products that Celltrion is developing. Until now, complex biotechnology medicines such as Remicade - given by injection or infusion - have been largely immune from generic competition, unlike conventional pills. But the picture is starting to change as regulators set out a clearer path for the evidence needed to secure approval of such products. That poses a threat to makers of multibillion-dollar drugs for diseases such as cancer and rheumatoid arthritis - and an opportunity for the likes of Celltrion. Europe has already approved some simpler biosimilars, including copycat versions of human growth hormone and the anaemia treatment EPO, but it has yet to approve an antibody drug such as Remicade, which is known generically as infliximab. Unlike traditional chemical drugs, biotech medicines consist of proteins derived from living organisms that cannot be replicated exactly. Biosimilars, therefore, are more difficult to develop and need more tests to prove they work properly. Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. Link this Share this Digg this Email Reprints

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