WARSCHAU, Polen–(BUSINESS WIRE)– Polpharma Biologics Group kondigt aan dat haar joint venture met Santo Holding (Strüngmann Group), Bioeq, een commerciële samenwerking heeft gesloten met Teva Pharmaceutical Industries Ltd. voor hun biosimilar kandidaat van het oogheelkundige geneesmiddel Ranibizumab (Lucentis ®) in Europa, Canada, Israël en Nieuw-Zeeland.

Het referentieproduct is een monoklonaal anti-angiogeen antilichaamfragment (Fab) dat is goedgekeurd voor de behandeling van het “natte” type leeftijdsgebonden maculaire degeneratie, een veel voorkomende vorm van leeftijdsgebonden verlies van het gezichtsvermogen. Wereldwijd worden minstens 25 tot 30 miljoen mensen getroffen door leeftijdsgebonden maculaire degeneratie. De lancering van een biosimilar Ranibizumab kan de marktconcurrentie vergroten, de kosten verlagen en de toegang voor patiënten uitbreiden met bewezen analytische en klinische gelijkenis met het oorspronkelijke product.

Polpharma Biologics Group Announces That Its Joint Venture Company, Bioeq, Has Entered Into a Commercialization Agreement for Biosimilar Ranibizumab

WARSAW, Poland–(BUSINESS WIRE)– Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has concluded a commercial partnership with Teva Pharmaceutical Industries Ltd. for their biosimilar candidate of the ophthalmological drug Ranibizumab (Lucentis®) in Europe, Canada, Israel and New Zealand.

The reference product is a monoclonal anti-angiogenic antibody fragment (Fab) that has been approved to treat the “wet” type of age-related macular degeneration, a common form of age-related vision loss. Worldwide, at least 25 to 30 million people are affected by age-related macular degeneration. The launch of a biosimilar Ranibizumab can increase market competition, reduce cost and expand patient access with proven analytical and clinical similarity to the original product.

This agreement with Teva complements an existing agreement concluded with Coherus BioSciences, Inc. for commercialisation in the United States.

Dr Joerg Windisch, CEO of the Polpharma Biologics Group, commented on the achievements of the joint venture:

“This is a huge milestone for the progression of a life changing therapeutic. We are proud the development program has been successfully completed, and that, through this agreement, more patients will gain access to highly effective treatments for vision loss including for age-related macular degeneration. This is another demonstration of our passion for providing safe and effective medicines to patients.”

About the Ranibizumab biosimilar

The Ranibizumab biosimilar, FYB201, was originally licensed in from Formycon AG (FRA: FYB/ WKN A1EWVY), a leading German biosimilars company, and subsequently developed by Bioeq AG, a joint venture between Polpharma Biologics and Santo Holding AG (Strüngmann Group). Phase III clinical trials for FYB201 have clinically demonstrated that the efficacy of FYB201 in patients with nAMD is comparable to that of Lucentis®.

Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Biosimilars exhibit proven analytical and clinical similarity to their respective branded reference products.

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About the Polpharma Biologics Group

Polpharma Biologics Group is a biopharmaceutical group focused on the development and manufacture of biosimilars. It provides fully integrated solutions along the biopharmaceutical value chain including cell line development, product and process development and clinical and commercial scale manufacturing to support the development of its proprietary portfolio of products and those of industry partners around the globe.

Polpharma Biologics has two sites in Poland, an advanced research and development center in Gdansk and a commercial scale manufacturing facility in Warsaw. It also has a research center in the Netherlands.

It is the largest Polish biotechnological firm developing and manufacturing biosimilars. It has been active for over 10 years on a scale previously unknown in the Polish biotechnological sector, investing not only in labs and production lines, but also in know-how, creating highly specialised work places and developing co-operation between business and science.

The Group currently employs over 800 people in Poland, including top-class specialists from the country and from around the world.

Learn more at www.polpharmabiologics.com

About Bioeq

Bioeq AG is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group. Bioeq develops, licenses and commercializes biosimilars.

Learn more at www.bioeq.ch

About Teva

Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. Teva is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with an established presence in generics, they have significant innovative research and operations supporting a growing portfolio of specialty and biopharmaceutical products.

Learn more at www.tevapharm.com.

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Contacts

Joseph Reeds

Head of Marketing

Polpharma Biologics

M +44 7807832776

E joseph.reeds@polpharmabiologics.com