Formycon AG

Health Canada approved FYB202/Otulfi®, a biosimilar to Stelara®, for treating inflammatory diseases. Formycon and Fresenius Kabi, partners in this venture, aim to enhance patient access to essential medicines and reduce healthcare costs. The approval follows similar nods from the FDA and European Commission, marking a significant step in biosimilar adoption.

Health Canada approved Otulfi® (FYB202), a biosimilar to Stelara®, for treating serious inflammatory diseases via subcutaneous and intravenous formulations. This follows approvals by the FDA and European Commission. Formycon AG and Fresenius Kabi plan to commercialize Otulfi® in Canada, enhancing access to affordable biosimilars and reducing healthcare costs.

Fresenius Kabi Canada's OtulfiTM, an ustekinumab biosimilar, received Health Canada approval for treating Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This expands their immunology biosimilar portfolio, offering cost-effective treatment options. OtulfiTM, comparable to Stelara®, is available in subcutaneous and intravenous forms, supported by KabiCare® patient program.

Health Canada approved Otulfi® (ustekinumab), a biosimilar to Stelara®, for treating serious inflammatory diseases via subcutaneous and intravenous formulations. This follows approvals by the FDA and European Commission. Formycon AG and Fresenius Kabi aim to enhance patient access to essential medicines and reduce healthcare costs, with commercialization in Canada set as per a March 2024 agreement.

Health Canada approved Formycon AG and Fresenius Kabi's FYB202/Otulfi®, a biosimilar to Stelara®, for treating several conditions. This follows U.S. FDA and European Commission approvals. The approval, based on comprehensive data, supports Formycon's mission to enhance access to affordable medicines and reduce healthcare costs.

FDA-approved biosimilars for IBD and inflammatory diseases, launching in 2025, aim to improve access, reduce costs, and expand treatment options.

The Global Biopreservation Market is projected to grow from US$5.44 billion in 2024 to US$24.51 billion by 2033, driven by personalized medicine, biotechnology advancements, and rare disease awareness. Key players include Thermo Fisher Scientific, Cryport, Eppendorf, BioLife Solutions, Azenta, Merck KGaA, Qiagen, and Chart Industries.

The EMA CHMP gave positive opinions for Celltrion's three biosimilars, including Eydenzelt (biosimilar aflibercept), Stoboclo and Osenvelt (biosimilar denosumab), and Avtozma (biosimilar tocilizumab). The European Commission will decide on marketing authorisations. Eydenzelt is recommended for treating multiple retinal disorders and met equivalence criteria in a Phase III study. Celltrion's Taehun Ha emphasized the company's commitment to affordable, high-quality treatments in Europe.

First Berlin Equity Research maintains 'Buy' rating for Formycon AG with a target price of €82, despite a 31.7% revenue drop to €41.1 million due to decreased milestone income from FYB201 and FYB203 biosimilars. FYB201 continues to generate revenue, FYB203 is expected to launch next year, and the upcoming FYB202 biosimilar launch, with FDA and EMA approvals, is significant. Royalty income from FYB202 could reach triple-digit million euros by 2026, supporting the favorable stock valuation.

Formycon AG and MS Pharma enter licensing and supply agreement for FYB202/ustekinumab biosimilar in MENA region. MS Pharma to commercialize and produce FYB202 locally in Saudi Arabia. Formycon retains rights for MENA region after licensing FYB202 globally to Fresenius Kabi in 2023.