12:09 uur 06-08-2021

Polpharma Biologics Group kondigt aan dat haar joint venture Bioeq een Biologics License Application (BLA) voor Biosimilar Ranibizumab heeft ingediend bij de Amerikaanse Food and Drug Administration (FDA)

WARSCHAU, Polen–(BUSINESS WIRE)– Polpharma Biologics Group kondigt aan dat haar joint venture met Santo Holding (Strüngmann Group), Bioeq, een biologische licentieaanvraag (BLA) heeft ingediend bij de Amerikaanse Food and Drug Administration (FDA) voor hun biosimilar kandidaat voor het oogheelkundige geneesmiddel Ranibizumab (Lucentis®).

Het referentieproduct is een monoklonaal anti-angiogeen antilichaamfragment (Fab) dat wordt gebruikt voor de behandeling van verschillende soorten maculaire degeneratieve ziekten, zoals neovasculaire (natte) leeftijdsgebonden maculaire degeneratie, diabetische retinopathie, maculaire oedemen en myope choroïdale neovascularisatie. 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. Het werkt door remming van de vasculaire endotheliale groeifactor (VEGF), die verantwoordelijk is voor de overmatige vorming van bloedvaten in het netvlies.

Polpharma Biologics Group Announces That Its Joint Venture Bioeq Has Submitted a Biologics License Application (BLA) for Biosimilar Ranibizumab to the U.S. Food and Drug Administration (FDA)

WARSAW, Poland–(BUSINESS WIRE)– Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for their biosimilar candidate of the ophthalmological drug Ranibizumab (Lucentis®).

The reference product is a monoclonal anti-angiogenic antibody fragment (Fab) used to treat various types of macular-degenerative diseases such as neovascular (wet) age-related macular degeneration, diabetic retinopathy, macular edemas and myopic choroidal neovascularization. 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. It works by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

Subject to FDA’s approval of this BLA, the product will be exclusively commercialized by Coherus BioSciences, Inc. in the United States.

Said submission represents the most recent milestone for Bioeq’s ranibizumab biosimilar program and compliments marketing authorization applications submitted to EMA and UK MHRA already in July this year.

Dr Joerg Windisch, CEO of the Polpharma Biologics Group, commented:

“The submission of a BLA to the FDA is a major milestone for any therapeutic and brings hope to patients across the US. This announcement carries a tangible promise of treatment choice and improved access to those who suffer from debilitating vision loss, including age-related macular degeneration. This is another representation of our commitment to providing safe and effective medicines to patients.”

1)Lucentis® is a registered trademark of Genentech Inc.

About Ranibizumab biosimilar

The Ranibizumab biosimilar, previously designated as FYB201 (and also known as CHS-201), has been originally licensed 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®.

About biosimilars

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.

About Polpharma Biologics Group

The Polpharma Biologics Group creates quality biosimilars with a passion to improve lives of patients. The group has built an extensive and growing pipeline of biosimilars to treat a number of medical conditions across major therapeutic areas. Several of these biosimilar assets have already been commercially partnered with the world’s largest biopharmaceutical companies.

The group operates a network of state-of-the-art development and manufacturing facilities across Europe, actively investing in technology, people and know-how, employing over 800 specialists from around the globe.

Learn more at www.polpharmabiologics.com

About Bioeq

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



Joseph Reeds

Head of Marketing, Polpharma Biologics


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