Business Wire

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)

Share

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.

www.bioeq.ch

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Joseph Reeds
Head of Marketing
M +447807832776
E joseph.reeds@polpharmabiologics.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Ricardo Signs a £2.3m Contract to Provide Technical Oversight for Taipei’s New Metro Route28.10.2021 01:01:00 CEST | Press release

Ricardo is pleased to announce it has been appointed by the Taipei City Government to provide Independent Verification and Validation (IV&V) services for Phase Two of the Wanda–Shulin line, a driverless metro route under construction in Taipei, Taiwan, for a total of £2.3M. Our teams will assess whether the electrical and mechanical sub-systems - including rolling stock, infrastructure, communications and power supply - and their interfaces with civil and track works meet the client’s required standards for functionality, quality and operational safety. A key responsibility will be ensuring that Phase Two, a mostly elevated 11km section that is due to open in 2028, will integrate seamlessly with Phase One, a 9.5km underground section that is expected to commence passenger service in 2025. The completed line, which will be known on the Taipei Metro network as the ‘Light Green’ line, will operate with driverless technology (Grade-of-Automation 4) throughout. Mr. Jan, Deputy Chief Enginee

KartRider: Drift Closed Beta Announced at Sony’s State of Play Event28.10.2021 00:10:00 CEST | Press release

The next entry in Nexon’s phenomenally successful KartRider racing franchise is almost here! Announced during today’s Sony State of Play event,cross-platform sensation KartRider: Drift will launch its Closed Beta beginning December 8, at 4pm Pacific, through December 15, ending at 5am Pacific. Access to the KartRider: Drift Closed Beta will be available for PC on Nexon’s launcher and Steam, in addition to being available to console players on Xbox One and, for the first time, PlayStation® 4. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211027006157/en/ KartRider: Drift Closed Beta Announced at Sony’s State of Play Event (Graphic: Business Wire) Gearing up to deliver new thrills in the beloved Nexon racing franchise, KartRider: Drift offers unparalleled character and kart customization. Karts can be tailored as never before, allowing players to transform their rides to reflect their inner racing persona. To help make sure y

Takeda to Acquire GammaDelta Therapeutics to Accelerate Development of Allogeneic γδT Cell Therapies Addressing Solid Tumors27.10.2021 18:46:00 CEST | Press release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the exercise of its option to acquire GammaDelta Therapeutics Limited (“GammaDelta”), a company focused on exploiting the unique properties of gamma delta (γδ) T cells for immunotherapy. Through the acquisition, Takeda will obtain GammaDelta’s allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms, which includes both blood-derived and tissue-derived platforms, in addition to early-stage cell therapy programs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211027005677/en/ “We’re committed to developing cell therapies that will have an impact on large segments of patients by focusing on off-the-shelf, allogeneic cell therapies that are highly accessible and have the potential to address solid tumors. Collaborating with scientific innovators with unique technology platforms and deep domain expertise, such as the GammaDelt

FiRa Consortium Hits Major Milestones in Ultra-Wideband Momentum27.10.2021 18:00:00 CEST | Press release

The FiRa™ Consortium, a catalyst for bringing leading innovators together to drive Ultra-Wideband (UWB) expansion, is today announcing two milestones in the market acceptance of UWB technology. The first is the launch of the initial phase of its certification program aimed at driving interoperability between UWB devices. At the same time, FiRa Consortium is announcing it has now surpassed 100 members, including all of the top handset manufacturers globally, plus market leaders across semiconductors, networking, secure access, and consumer technology. “UWB is fast becoming a pillar of wireless local connectivity technology alongside Wi-Fi and Bluetooth,” said Charlie Zhang, Board Chair of FiRa Consortium. “When combined with the membership momentum we are seeing, our certification program signifies that the market is prepared and ready for broad implementation of UWB across market sectors.” FiRa Consortium’s certification program is the first to provide baseline testing and certificatio

Mitsubishi Corporation Life Sciences to Accelerate Next Wave of Digital Transformation and Business Growth by Switching to Rimini Street Support27.10.2021 18:00:00 CEST | Press release

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that Mitsubishi Corporation Life Sciences, a food ingredients manufacturer within Mitsubishi Corporation’s Food Industry Group, has switched to Rimini Street Support for its JD Edwards applications. Switching from the vendor’s support to Rimini Street has enabled the company to dramatically reduce its maintenance costs and free up internal resources for strategic initiatives. By freeing up critical resources – time, money and personnel – Mitsubishi Corporation Life Sciences is able to begin investing in its digital transformation initiatives for the next five to 10 years and establish a foothold for further business expansion, both locally and overseas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211027005

CURACLE and Théa Announce Licensing and Collaboration Agreement for the Development and Commercialization of Orally Administered Treatment for Diabetic Macular Edema and Wet-AMD27.10.2021 17:47:00 CEST | Press release

CURACLE, a Korea-based biopharmaceutical company, today announced that it has entered into an exclusive license and collaboration agreement with Théa Open Innovation, the sister company of Théa, Europe’s number one independent ophthalmic company with a 150-year history, for the development and commercialization of CURACLE’s CU06-RE, that has the potential to become the first orally administered treatment for diabetic macular edema and wet age-related macular degeneration (wet-AMD). Under the terms of the agreement, CURACLE will receive an upfront payment of $6 million and could receive up to an additional $157.5 million in potential development, regulatory and sales milestones, as well as royalties on sales if CU06-RE is successfully developed, which will entitle CURACLE to receive up to $2 billion in total payments. Théa and CURACLE will closely collaborate on the clinical development of this novel oral drug. CURACLE will be responsible for the Phase I and II clinical studies with TOI

Everbridge Selected to Power the Nationwide Public Alert System for Spain27.10.2021 15:29:00 CEST | Press release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM) and national Public Warning solutions, today announced the selection by Spain to deploy its next-generation population alerting technology to help keep the country’s more than 120 million residents and visitors safe and informed in case of an emergency. Everbridge announced the contract award anonymously in a press release last month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211027005638/en/ Everbridge Selected to Power the Nationwide Public Alert System for Spain (Graphic: Business Wire) The new country-wide public alert system of Spain will include both Cell Broadcast coverage at the national level, as well as the publication of alerts via the Web and through mobile alerts, powered by Everbridge. The state-of-the-art alert system will reach 99% of the population of Spain, including 47 million residents and nearly 80 million annual v