Formycon Announces Positive Clinical Data For Keytruda Biosimilar Candidate FYB206 (pembrolizumab)

• Dahlia-PK study demonstrates pharmacokinetic equivalence of FYB206 (pembrolizumab) with the reference drug Keytruda
• Positive clinical data from the pivotal study underline Formycon's excellent position in the leading group of pembrolizumab biosimilar developers.
• Focus on completing the development and preparation of the regulatory dossiers

Formycon AG announces that the primary endpoint of the pivotal Dahlia pharmacokinetics study (PK study) has been met. The randomized, double-blind, multicenter clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 with the oncology blockbuster drug Keytruda¹ ( pembrolizumab).

Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG , commented: “The exceptionally rapid achievement of this further important milestone in our clinical development program confirms not only our scientific expertise but also our particular competence in the efficient conduct of clinical trials. The positive results of the Dahlia-PK study underscore our strong position as one of the leading developers of biosimilars for one of the most important biological drugs. They validate both the strategy of our optimized clinical development program for the Keytruda biosimilar candidate FYB206 and the high quality of our study design and management. This brings us a crucial step closer to our goal of making FYB206 available worldwide as quickly as possible and significantly improving access to this important medication for patients.”

In early 2025, Formycon agreed on an optimized clinical strategy with the U.S. Food and Drug Administration (FDA) that sufficiently demonstrates the therapeutic comparability of FYB206 to the reference drug Keytruda based on comprehensive analytical data and data from the Dahlia-PK study. Having achieved the primary study endpoint, Formycon is now focusing on completing all development activities to finalize the regulatory submissions. The company is working closely with the relevant authorities to make FYB206 available as soon as possible after the reference drug's exclusivity expires. Meanwhile, patients from the Dahlia study will continue to receive optimal clinical care.

Pembrolizumab is a humanized monoclonal antibody belonging to the class of immune checkpoint inhibitors and can be used to treat numerous cancers. Due to this broad range of indications in oncology, global sales of Keytruda increased again by 7% year-over-year in 2025, reaching US$31.7B. Keytruda thus maintains its leading position among the world's best-selling drugs.

About Formycon
Formycon AG is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical drugs. The company focuses on therapies in ophthalmology, immunology, immuno-oncology, and other key therapeutic areas, covering nearly the entire value chain from technical development and clinical trials to regulatory submission and approval. Formycon relies on strong, trusted, and long-term partnerships worldwide to commercialize its biosimilars. Formycon already has two biosimilars on the market: FYB201/ranibizumab and FYB202/ustekinumab. A third biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four additional biosimilar candidates—including FYB208/dupilumab—are currently in development. With its biosimilars, Formycon makes an important contribution to enabling as many patients as possible to access highly effective and affordable medications.

For more information, visit www.formycon.com

About Biosimilars
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection—including 45 blockbuster drugs with estimated total annual sales of more than US$200B worldwide. Biosimilars are follow-on products of biopharmaceutical drugs whose market exclusivity has expired. They are approved in highly regulated markets such as the EU, the US, Canada, Japan, and Australia following rigorous regulatory processes. Biosimilars create competition, thus enabling more patients to access biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars are currently around US$21B. Analysts predict that sales could rise to more than US$74B by 2030.

¹ Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ/USA

² https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/