Hospira launches RA biosimilar in Western Europe as Remicade patent expires

The first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), has been launched in major European markets by Hospira.

The treatment received a positive opinion from the European Medicines Agency’s CHMP in 2013 but its reference product Remicade was given a paediatric licence extension until February 2015, delaying the introduction of Inflectra to major European markets until now.

The development is an early boost for Pfizer, which struck a $17 billion deal to buy Hospira two weeks ago, extending its already large footprint in generics and strengthening its position in biosimilars. Remicade has been authorised in the EU since 1999 and had European sales of almost €2 billion in 2013.

Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis and plaque psoriasis.

Biologic medicines have transformed the lives of people living with chronic inflammatory conditions, but they are complex and expensive to produce, limiting patient access in some markets.

A biosimilar developed in line with EU requirements can be considered a therapeutic alternative to an existing biologic, and competition in the market as new biosimilars are introduced is predicted to save the European health systems over €20 billion by 2020.

“Inflectra has already been launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry, and has already been prescribed to treat patients in all its licensed indications. We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra,” said Paul Greenland, vice president biologics, Hospira.

Inflectra’s launch in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden extends its availability to 24 European countries.

Hospira’s partner, Celltrion, has also submitted an application to the US Food and Drug Administration for biosimilar infliximab, although the regulatory pathway is far slower there for biosimilars.

Hospira has one of the largest biosimilar pipelines in the industry based on more than seven years’ of market experience in their development. It currently has several biosimilars on the European market, including Inflectra (infliximab), Retacrit (epoetin zeta) and Nivestim (filgrastim).


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