Formycon AG

Formycon AG successfully completed patient enrollment for its Dahlia pharmacokinetic study with 96 participants, comparing biosimilar candidate FYB206 to Keytruda in melanoma patients.

Formycon AG has entered into a distribution agreement with Teva's subsidiary Ratiopharm for the semi-exclusive commercialization of its Stelara biosimilar FYB202, branded as Fymskina, in Germany.

Valorum Biologics LLC has secured exclusive commercialization rights for FYB203/AHZANTIVE®, Formycon's biosimilar to Eylea®, in the United States and Canada through a licensing agreement with Klinge Biopharma GmbH.

Formycon AG announced plans to issue a four-year corporate bond with a target volume of €50 million to fund the development and expansion of its biosimilar product portfolio.

Brazil's regulatory authority ANVISA has granted marketing authorization for Ranivisio (FYB201), marking the first approved Lucentis biosimilar in the country with launch expected in Q4 2025.

Formycon's FYB202 demonstrated analytical and functional comparability to reference ustekinumab (Stelara®) through comprehensive laboratory testing and clinical studies.

Formycon terminates Phase III "Lotus" trial for FYB206 biosimilar after FDA confirms therapeutic comparability can be demonstrated through existing melanoma study data and analytical program.

Teva Pharmaceuticals secured semi-exclusive commercialization rights for FYB203 (AHZANTIVE), Formycon's aflibercept biosimilar, across major European markets and Israel following FDA approval in June 2024.

Formycon AG and MS Pharma have entered into a licensing and supply agreement for the commercialization of FYB202, a biosimilar to Stelara® (ustekinumab), in the Middle East and North Africa (MENA) region.

• The European Medicines Agency's CHMP has recommended FYB203, an aflibercept biosimilar, for marketing authorization. • FYB203 is intended for treating neovascular age-related macular degeneration, diabetic macular edema, and other retinal diseases. • The European Commission is expected to make a final decision on approval in the second half of January 2025. • FYB203, already FDA-approved, will be marketed as AHZANTIVE and Baiama in the European Union.