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Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA

DGAP-News: Formycon AG / Key word(s): Miscellaneous/Regulatory Admission
01.03.2021 / 07:00
The issuer is solely responsible for the content of this announcement.


Press Release // March 1, 2021

Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA

- Pre-BLA-interaction with U.S. Food and Drug Administration (FDA) confirms planned resubmission in first half of 2021

- Submission of the marketing authorization to the European Medicines Agency (EMA) in immediate consequence

- Submission for other highly regulated territories in preparation

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") confirm the planned timeline for resubmission of the Biologics License Application ("BLA") for their Lucentis(R) biosimilar candidate FYB201 following a successful pre-BLA interaction with the U.S. Food and Drug Administration (FDA).

As announced in November 2020, the initial submission strategy of the Lucentis(R) biosimilar candidate FYB201 has been adjusted as part of a simplification of the approval procedure. With the optimization of the commercial supply chain, the approval for FYB201 will directly occur in a large commercial scale. In the context of the interaction with the FDA, the data requested by the authorities have been reviewed and the further procedure has been aligned. The BLA-submission is expected to be filed with the U.S. Food and Drug Administration on schedule during the first half of 2021. Submission to the European Medicines Agency (EMA) is expected to follow-up.

In addition to the approval in the United States of America and the countries of the European Union, Formycon and Bioeq are seeking approval of the biosimilar candidate to Lucentis(R) (ranibizumab) in other highly regulated territories such as Canada, Australia, the United Kingdom and Switzerland.

* Lucentis(R) is a registered Trademark of Genentech Inc.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

About Bioeq:
Bioeq was founded in 2014 and is a leading service provider in the development of biopharmaceutical follow-on products, known as biosimilars. Working with various partners, Bioeq develops third-wave biosimilars and specializes in ophthalmic agents. The development programs meet the standards for highly regulated markets such as Europe, the USA, Canada, or Japan, and are therefore suitable for global licensing. Bioeq's expertise lies primarily in comprehensive project management, clinical development, the drafting of licensing strategies in dialog with the authorities, the development of application systems for administering the products, the drawing-up of patent strategies, and in license management. Bioeq is currently working on five different biosimilar projects.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.

Sabrina M├╝ller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110 //

This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

01.03.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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Language: English
Company: Formycon AG
Fraunhoferstra├če 15
82152 Planegg-Martinsried
Phone: 089 864667 100
Fax: 089 864667 110
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1171787

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Last Updated: 01-Mar-2021