Formycon starts phase III trial for Keytruda® biosimilar FYB206
Formycon AG, a prominent developer of biosimilars based in PLANEGG-MARTINSRIED, Germany, has initiated a significant Phase III clinical trial named "Lotus." This trial is set to evaluate the safety and efficacy of FYB206, a pembrolizumab biosimilar, in comparison to the widely used immuno-oncology drug Keytruda®. The first patient has already been enrolled, marking an essential milestone in this study.
The "Lotus" study is a double-blind, multicenter trial focusing on patients with non-small cell lung cancer (NSCLC). It aims to assess the best overall response rate (bORR) over 17 treatment cycles spanning 40 weeks. Throughout this period, changes in tumor size will be meticulously documented using advanced imaging techniques. Post the comparative treatment phase, the therapy will extend for another 12 months to ensure comprehensive data collection.
The trial's design has been meticulously constructed in collaboration with major regulatory bodies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The study is being conducted across multiple countries in Eastern Europe and Southeast Asia. It runs concurrently with a Phase I study initiated in mid-June, which examines the pharmacokinetics, safety, and tolerability of FYB206 against Keytruda® in patients with malignant melanoma, another form of cancer.
Dr. Andreas Seidl, the Chief Scientific Officer at Formycon AG, emphasized the significance of this trial within the realm of immuno-oncology. He highlighted the proven efficacy of pembrolizumab in treating various cancer types and the ongoing studies aiming to broaden its application spectrum. This underscores the immense potential of FYB206 both medically and economically. Given the rising global demand and increased usage in early cancer stages, Keytruda® has seen a 20% rise in sales in the first quarter of 2024 alone.
Pembrolizumab, the active ingredient in Keytruda®, functions as an immune checkpoint inhibitor and is used for treating multiple cancers, including NSCLC. Tumor cells often manipulate immune checkpoints to evade the body's defenses. Pembrolizumab targets the PD-1 checkpoint, enabling T cells to effectively combat and destroy cancer cells.
Formycon anticipates that, subject to regulatory approval, FYB206 could enter the market after the reference product's market exclusivity expires in the USA by 2029 and in the EU by 2030. Initial results from the Phase I trial are expected in 2026, with preliminary results from the Phase III trial projected for 2027.
About Formycon:
Formycon AG is a leading independent developer of high-quality biosimilars. The company specializes in various therapeutic areas including ophthalmology, immunology, and immuno-oncology. Formycon covers nearly the entire value chain from technical development to regulatory approval and relies on strong global partnerships for commercialization. Currently, Formycon has one biosimilar, FYB201/Ranibizumab, available in Europe and the USA, with five more candidates in development. The company aims to make effective and affordable medicines accessible to a broader patient population. Formycon AG is listed on the Frankfurt Stock Exchange and is headquartered in Munich.
About Biosimilars:
Biosimilars are follow-on products to biopharmaceutical drugs that have lost market exclusivity. Approved under stringent regulatory processes, they create competition and improve access to biopharmaceutical therapies while reducing healthcare costs. As patents for many biopharmaceuticals expire by 2032, including 45 blockbuster drugs, the market for biosimilars is expected to grow significantly, potentially reaching over $74 billion by 2030.
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