Formycon AG has achieved a significant milestone in its biosimilar development program with the enrollment of the first patient in its Phase III clinical trial for FYB206, a biosimilar candidate for Merck's blockbuster immunotherapy Keytruda (pembrolizumab). The German biotechnology company announced that the double-blind, multicenter "Lotus" study will compare the safety and efficacy of FYB206 with the reference drug in patients with non-small cell lung cancer (NSCLC).
Phase III Trial Design and Objectives
The Lotus study is designed to evaluate the best overall response rate (bORR) in NSCLC patients, with treatment comprising up to 17 cycles within 52 weeks. Changes in tumor size will be continuously monitored using imaging techniques throughout the comparative treatment period, followed by an additional 12 months of therapy continuation.
The study design was developed in close coordination with major regulatory authorities including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The trial is being conducted across multiple countries in Eastern Europe and Southeast Asia.
Parallel Phase I Development
Running concurrently with the Phase III trial is a Phase I study called "Dahlia," which began in mid-June. This study compares the pharmacokinetics, safety, and tolerability of FYB206 with Keytruda in patients with malignant melanoma. The Phase I trial focuses on preventive monotherapy with pembrolizumab following complete surgical removal of melanoma tumors, aiming to minimize recurrence risk over a one-year treatment period.
Market Opportunity and Commercial Potential
Keytruda represents one of the most significant commercial opportunities in biosimilar development. The immune checkpoint inhibitor generated $25 billion in sales in 2023, making it the world's best-selling drug. Sales increased by 20% year-on-year in the first quarter of 2024, with projections suggesting worldwide sales could reach $30 billion by 2026.
The growing market opportunity is driven by increasing cancer diagnoses globally. The International Agency for Research on Cancer (IARC) predicts a 77% increase in cancer cases by 2050, supporting continued growth in pembrolizumab demand.
Mechanism of Action and Clinical Applications
Pembrolizumab is a humanized monoclonal antibody that functions as an immune checkpoint inhibitor. The drug binds to the PD-1 receptor and blocks the interaction between PD-1 and its ligand PD-L1, enabling the body's T cells to recognize and eliminate cancer cells that would otherwise evade immune detection.
Non-small cell lung cancer represents one of numerous cancer indications for which pembrolizumab is approved. The drug's broad oncology applications and demonstrated efficacy across multiple tumor types contribute to its commercial success and the potential value of biosimilar alternatives.
Development Timeline and Market Entry
Formycon anticipates the earliest market entry for FYB206 following the expiry of Keytruda's market exclusivity in the United States from 2029 and in the European Union from 2030. First results from the Phase I trial are expected in 2026, with preliminary Phase III results to follow in 2027.
"The start of the Phase III clinical trial represents an important milestone for us in order to provide an effective, safe and cost-effective treatment option for many severely ill cancer patients worldwide in the future," commented Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG.
Broader Biosimilar Market Context
The biosimilar market represents a significant opportunity as biopharmaceutical patents expire. By 2032, 45 blockbuster drugs with an estimated total annual global turnover of more than $200 billion will lose patent protection. Global biosimilar sales currently amount to approximately $21 billion and could rise to over $74 billion by 2030, according to analyst projections.
Formycon already has established biosimilar products on the market, including FYB201/ranibizumab and FYB202/ustekinumab in Europe and the USA, with FYB203/aflibercept recently approved by the FDA, EMA, and MHRA. The company maintains four additional biosimilar candidates in development beyond FYB206.
