FDA grants approval for Eylea®¹⁾ biosimilar FYB203/AHZANTIVE®²⁾ (aflibercept-mrbb)

Important Notice:
This announcement and the information contained herein are for informational purposes only and do not constitute a prospectus or an offer to sell or a solicitation of an offer to buy any securities of the Company in the United States of America (including its territories and possessions, the states of the United States of America and the District of Columbia) (“United States”) or any other jurisdiction. This publication may not be distributed, published or circulated in the United States, Australia, Canada, Japan and other countries where such distribution or publication may be unlawful.

The Company’s securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act, or in a transaction not subject to the registration requirements of the Securities Act. or the applicable securities laws of Australia, Canada or Japan. There will be no public offering of shares of the Company.

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About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market (“Scale”) of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).

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 2025, 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. Currently, global sales of biosimilars are estimated at more than USD 15 billion. By 2030, analysts estimate that this figure could rise to over USD 74 billion.