12:08 uur 04-10-2021

Polpharma Biologics Group kondigt aan dat de Biologics License Application (BLA) ingediend door haar Joint Venture Bioeq voor haar biosimilar ranibizumab, is geaccepteerd voor beoordeling door de Amerikaanse Food en Drug Administration (FDA)

WARSCHAU, Polen–(BUSINESS WIRE)– Polpharma Biologics Group kondigt aan dat haar joint venture met Santo Holding (Strüngmann Group), Bioeq, een kennisgeving heeft ontvangen van de Amerikaanse Food en Drug Administration (FDA) dat de biologics license application (BLA) voor de voorgestelde biosimilar (formeel ook bekend als BQ201, FYB201, CHS-201) voor Lucentis®, een blockbuster oftalmologisch geneesmiddel dat ranibizumab als werkzame stof bevat, is goedgekeurd voor beoordeling.

De FDA heeft een beoogde actiedatum voor de aanvraag voor augustus 2022 toegewezen.

Het referentieproduct is een monoklonaal anti-angiogeen antilichaam fragment (Fab) dat is goedgekeurd voor de behandeling van het “natte” type leeftijdsgebonden maculaire degeneratie, een veel voorkomende vorm van leeftijdsgebonden verlies van 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 the Biologics License Application (BLA) Submitted by its Joint Venture Bioeq for its Biosimilar Ranibizumab has Been Accepted for Review by 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 received notification by the U.S. Food and Drug Administration (FDA) that the biologics license application (BLA) for its proposed biosimilar (formally also known as BQ201, FYB201, CHS-201) to Lucentis®, a blockbuster ophthalmological drug containing ranibizumab as active drug substance, has been accepted for review.

The FDA has assigned a target action date for the application for August 2022.

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 file acceptance represents the most recent milestone for Bioeq`s ranibizumab biosimilar program and compliments marketing authorization applications submitted to EMA in June and UK MHRA in July this year.

Subject to the FDA`s approval, BQ201 will be exclusively commercialized by Coherus BioSciences, Inc. in the United States.

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

“This file acceptance is validation of the huge effort put in by the team at Bioeq and its partners to bring treatment choice and improved patient access to the US market. It creates real promise for those who suffer from debilitating vision loss, including age-related macular degeneration.”

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

Information for editors

About Ranibizumab biosimilar

Bioeq`s proposed ranibizumab biosimilar BQ201, 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.



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