Formycon AG has announced a strategic partnership with Teva's subsidiary Ratiopharm for the commercialization of its Stelara biosimilar FYB202, branded as Fymskina, in Germany. The collaboration marks a significant expansion of Formycon's market presence and aims to increase patient access to high-quality biosimilars in the German healthcare market.
Partnership Structure and Timeline
Under the distribution agreement, Formycon will retain responsibility for manufacturing and supply of the finished product, while Ratiopharm will handle commercialization on a semi-exclusive basis. The market launch for Fymskina is planned for the third quarter of 2025.
"We aim to provide as many patients as possible with access to high-quality biosimilars while expanding our market presence in Germany. That's why we set the strategic course for semi-exclusive partnerships early on," explains Nicola Mikulcik, Chief Business Officer of Formycon AG.
Strategic Market Positioning
This partnership builds on Formycon's existing global commercialization agreement with Fresenius Kabi established in February 2023. Under that arrangement, Formycon retained secondary commercialization rights for Germany, parts of Latin America, and the MENA region to enable separate licensing to strong regionally focused distribution partners.
Fresenius Kabi has already successfully launched FYB202/Otulfi in the US and various European markets, including Germany in March 2024. The addition of Teva/Ratiopharm as a second commercialization partner is expected to significantly increase market coverage in Germany.
Product Profile and Regulatory Status
FYB202/Fymskina is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play important roles in inflammatory and immune responses. In September 2024, Fymskina received approval from the European Commission for the treatment of moderate to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.
Established Partnership Foundation
Teva already commercializes Formycon's Lucentis biosimilar FYB201/Ranivisio in Europe, providing a foundation for this expanded collaboration. As one of the world's leading pharmaceutical companies, Teva leverages its expertise in the generics and biosimilars market to drive availability of modern medicines.
Under the new agreement for Fymskina commercialization in Germany, Formycon will receive milestone payments and a share of the gross margin.
Market Context
The biosimilars market represents a significant opportunity as biopharmaceutical drugs lose patent protection. By 2032, many biopharmaceutical drugs will lose their patent protection, including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Global sales of biosimilars currently amount to around 21 billion US dollars, with analysts projecting growth to over 74 billion US dollars by 2030.
