Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a
biosimilar to Eylea®2)

EQS-News: Formycon AG / Key word(s): Regulatory Approval
Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a
biosimilar to Eylea®2)

01.07.2024 / 06:50 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Press Release // July 01, 2024

Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a
biosimilar to Eylea®2)

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, 'Formycon') and its
licensing partner Klinge Biopharma GmbH ('Klinge') jointly announce that the
U.S. Food and Drug Administration ('FDA') approved FYB203/AHZANTIVE®
(aflibercept-mrbb), a biosimilar to Eylea®, on June 28, 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: 'The FDA approval of
FYB203/AHZANTIVE® is another key milestone on our way to becoming the
leading pure-play biosimilar developer. It highlights the expertise and
experience of our team. With the Eylea® biosimilar FYB203/AHZANTIVE® and our
already approved Lucentis®3) biosimilar FYB201, we have achieved an
outstanding position in ophthalmic biosimilar therapies. We are thus
improving healthcare for patients with retinal diseases by offering
effective, safe and, above all, affordable treatment options.'

FYB203/AHZANTIVE® obtained FDA approval for the treatment of patients with
Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious
retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy
(DR) and Macular Edema following Retinal Vein Occlusion (RVO). The active
ingredient inhibits the vascular endothelial growth factor ('VEGF'), which
is responsible for the excessive formation of blood vessels in the retina.
In 2023, Eylea® reached global sales of around US$ 9 billion4), confirming
its status as the currently best-selling drug in the field of anti-VEGF
therapies.

The FDA approval for FYB203/AHZANTIVE® is based on a thorough evaluation of
our comprehensive data package including analytical, pre-clinical, clinical
and manufacturing data. FYB203/AHZANTIVE® demonstrated comparable efficacy,
safety, pharmacokinetics and immunogenicity to the reference drug Eylea® in
patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).

In addition, a marketing authorization application for FYB203 was submitted
to the European Medicines Agency ('EMA') at the end of 2023. A decision by
EMA is expected by early 2025 at the latest.

1) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
2) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
3) Lucentis® is a registered trademark of Genentech Inc.
4) Source:
https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/


About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality
biosimilars, follow-on products of biopharmaceutical medicines. The company
focuses on therapies in ophthalmology, immunology, immuno-oncology and other
key disease areas, covering almost the entire value chain from technical
development through clinical trials to approval by the regulatory
authorities. For commercialization of its biosimilars, Formycon relies on
strong, well-trusted and long-term partnerships worldwide. With
FYB201/Ranibizumab, Formycon already has a biosimilar on the market in
Europe and the USA. Another five biosimilar candidates are currently in
development. With its biosimilars, Formycon is making an important
contribution to providing as many patients as possible with access to highly
effective and affordable medicines. Formycon AG is headquartered in Munich
and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 /
WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have
revolutionized the treatment of serious and chronic diseases. By 2032, many
of these drugs will lose their patent protection - including 45 blockbusters
with an estimated total annual global turnover of more than 200 billion US
dollars. Biosimilars are successor products to biopharmaceutical drugs for
which market exclusivity has expired. They are approved in highly regulated
markets such as the EU, the USA, Canada, Japan and Australia in accordance
with strict regulatory procedures. Biosimilars create competition and thus
give more patients access to biopharmaceutical therapies. At the same time,
they reduce costs for healthcare providers. Global sales of biosimilars
currently amount to around 21 billion US dollars. Analysts assume that sales
could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information
which are based on Formycon's 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.


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01.07.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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   Language:       English
   Company:        Formycon AG
                   Fraunhoferstraße 15
                   82152 Planegg-Martinsried
                   Germany
   Phone:          089 864667 100
   Fax:            089 864667 110
   Internet:       www.formycon.com
   ISIN:           DE000A1EWVY8
   WKN:            A1EWVY
   Indices:        Scale 30
   Listed:         Regulated Unofficial Market in Berlin, Dusseldorf,
                   Frankfurt (Scale), Hamburg, Munich, Stuttgart,
                   Tradegate Exchange
   EQS News ID:    1936215

End of News EQS News Service
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1936215 01.07.2024 CET/CEST