Ewopharma partners with Biogen to commercialise BENEPALI® and FLIXABI® in Central Eastern Europe

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Starting in 2017, Ewopharma will introduce Biogen's biosimilars BENEPALI® (etancercept) and FLIXABI® (infliximab) to six countries, Romania, Bulgaria, Croatia, Estonia, Latvia and Lithuania. BENEPALI and FLIXABI are indicated to treat a number of inflammatory diseases such as Rheumatoid Arthritis, Psoriasis and Inflammatory Bowel Disease.

Ewopharma

We hope that by introducing BENEPALI and FLIXABI in these countries, we will be able to help support the sustainability of healthcare systems whilst helping to expand access to these much-needed therapies.

A distribution agreement has been signed between Ewopharma and Biogen, one of the world’s oldest independent biotechnology companies, to market and sell the company’s anti-Tumor Necrosis Factor (anti-TNF) biosimilars. Starting in 2017, Ewopharma will bring BENEPALI® (etancercept) and FLIXABI® (infliximab) to six countries, Romania, Bulgaria, Croatia, Estonia, Latvia and Lithuania. BENEPALI and FLIXABI are indicated to treat a number of inflammatory diseases, including Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis and Inflammatory Bowel Disease.

“Ewopharma has a long-standing history of bringing new medicines to patients in Central Eastern Europe. We have a strategic focus to build on our successful hospital business and provide specialists with innovative products for medical conditions with high unmet medical need. We are therefore very pleased to partner with Biogen to bring their anti-TNF therapies to patients, physicians, and payers”, said Alain Staub, CEO and Chairman of the Board of Ewopharma. “We hope that by introducing BENEPALI and FLIXABI in these countries, we will be able to help support the sustainability of healthcare systems whilst helping to expand access to these much-needed therapies. These are important concerns globally, but particularly in Central Eastern Europe.”

BENEPALI® and FLIXABI® both inhibit the actions of Tumor Necrosis Factor-alpha (TNF-alpha), a key player of the immune system. TNF-alpha’s primary role is the regulation of immune cells in in the defence against viral infection, inhibition of tumorigenesis or response to sepsis to name but a few. If TNF-alpha is unregulated, however, this can lead to unwanted systemic inflammation, which causes the symptoms of rheumatoid arthritis or psoriasis for example. Inhibiting TNF-alpha’s pathological effects will therefore provide relief to sufferers of TNF-alpha-related autoimmune disorders such as rheumatoid arthritis.

BENEPALI® and FLIXABI® are among the first biosimilar anti-TNF therapies in Central Eastern Europe. A biosimilar medicine is a biological drug. It is a highly complex therapeutic product, which is made by a living organism or derived from a biological source. Most importantly, a biosimilar is a drug, which has been developed to be almost identical, or similar, to an existing biological drug, the reference medicine. The reference and the biosimilar medicine can only be similar and not identical because of their biological origin. Much like a generic, an authorised biosimilar will however generally be used at the same dose and to treat the same condition as the original reference medicine. For further information, see European Medicines Agency, EMA/837805/2011, 27 September 2012: “Questions and answers on biosimilar medicines (similar biological medicinal products)”.

About Ewopharma:

Ewopharma of Schaffhausen, Switzerland, is the innovative partner for the marketing of ethical pharmaceuticals and consumer health products in Central Eastern Europe. With over 50 years’ presence in the region, Ewopharma has extensive market knowledge and enjoys a privileged position in the area. Ewopharma covers all regulatory and commercial aspects of market access and development. Further information is available at http://www.ewopharma.com.

For further information, please contact:

Reto Schaberl, Head Business Development, Ewopharma AG
Tel. +41 52 633 09 91
r.schaberl(at)ewopharma.com

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Shila SCHNEIDER
Ewopharma
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