LONDON, Sept 10 (Reuters) - The European Commission has approved the first copycat version of an antibody-based drug, clearing the way for increased competition for the makers of multi-billion dollar biotechnology drugs to treat complex diseases.
Tuesday’s final green light for Inflectra - which was developed by South Korea’s Celltrion and will be marketed by U.S. company Hospira - had been expected following a European Medicines Agency recommendation in June.
Hospira said the drug for treating rheumatoid arthritis and some other conditions would be launched throughout Europe “at the earliest opportunity taking into account any relevant patent protection”.
Inflectra is a so-called biosimilar version of Johnson & Johnson and Merck & Co’s Remicade.
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.
Until now biotech medicines like Remicade, given by injection or infusion, have been largely immune from generic competition, unlike conventional pills.
But Europe’s approval of the Celltrion/Hospira product shows the changing landscape as regulators set out a clearer path for the evidence needed to secure approval of such drugs.
Celltrion said in June it was planning to seek approval in Japan later this year and that an application for U.S. approval is possible in 2015.