First biosimilar antibody drug approved by Europe

LONDON (Reuters) – As per the reports recieved, the European Commission has passed the first similar version of an antibody-based drug. This is a good news as it will help in paving the way for raising competition for the manufacturers of multi-billion dollar biotechnology drugs to tackle complex diseases.

Finally a ray of light emerged on Tuesday, for Inflectra – Developed by South Korea’s Celltrion that will be marketed by U.S. company Hospira – had initially been thought to be following a European Medicines Agency recommendation in June.

As stated by Hospira the drug used for the treatment of rheumatoid arthritis and few other conditions would be launched throughout Europe “at the earliest opportunity taking into account any relevant patent protection”.

Inflectra as we discuss is kind of biosimilar version of Johnson & Johnson and Merck & Co’s Remicade.

Quite different from traditional chemical drugs, biotech medicines comprise of proteins that are derived from few living organisms cannot altogether be replicated in an exact way.

Hence, Biosimilars are way too difficult to develop and require a lot of tests and experiments so as to prove that they work perfectly.

Unlike various conventional pills, till now biotech medicines like Remicade, infused by injection, have proven to be highly immune from generic competition.

However Europe’s approval over the Celltrion/Hospira product indicates the changing arena as regulators pave out a better and clearer path for the proof needed to save approval of such drugs.

In June Celltrion had said that it had been planning to get approval in Japan later this year and that an application for U.S. approval is expected in 2015.

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