• First patient entered Phase I clinical trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda®* (First Patient In).
  • “Dahlia” investigates the PK equivalence as part of a preventive therapy for patients who have had a malignant melanoma (black skin cancer) completely surgically removed.
  • In the parallel Phase III trial “Lotus”, the safety and efficacy of FYB206 will be compared with the reference drug Keytruda® in patients with non-small cell lung cancer. Recruitment is expected to start very soon.
  • The start of clinical development of FYB206 underscores Formycon’s excellent position among the first three biosimilar companies announcing entry into the clinical development phase for the EU and US market.

Planegg-Martinsried – Formycon AG (FSE: FYB, “Formycon”) announced today that the clinical development program for FYB206, a biosimilar for Keytruda®* / pembrolizumab, has started with the inclusion of the first patient.

Dr. Stefan Glombitza, Chief Executive Officer (CEO) of Formycon AG, commented: “With the start of the clinical development program and the first patient in, we have reached a major milestone. We are at the forefront of the development of a pembrolizumab biosimilar. Our FYB206 project not only has immense commercial potential, but above all offers exceptional therapeutic options. We are doing absolutely everything we can to ensure that more cancer patients worldwide can be treated with this drug in the future. After all, only biosimilars combine quality and efficacy with cost efficiency and thus improve healthcare.”

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body’s own cellular anti-tumor immune response and kill cancer cells.

With its broad range of indications in oncology and sales of USD 25 billion in 2023[i], Keytruda® is currently the world’s best-selling drug. Due to the increasing number of cancers diagnoses around the world – the International Agency for Research on Cancer (IARC) predicts an increase of 77% by 2050[ii] – further growth in sales are forecasted for pembrolizumab over the coming years.

Formycon has started the clinical development program with a Phase I study to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda® / pembrolizumab in patients with malignant melanoma (black skin cancer). The first patient was included in the study. For melanoma patients, preventive monotherapy with pembrolizumab after complete surgical removal of the tumor aims to minimize the risk of recurrence. The study design of the “Dahlia” Phase I study was developed in close cooperation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and anticipates a treatment period of one year for the patients in the trial.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, added: “With our sophisticated study design, we excellently address both the complexity of the mode of action and the requirements of the regulatory authorities. To largely exclude disease-related influencing factors in the investigation of PK equivalence, we have chosen the study indication for the preventive treatment of patients after surgical removal of a melanoma. We are assuming that the influence of the tumor on the variability of the pharmacokinetic parameters is rather low. The fact that our team has successfully put together such a comprehensive clinical program fills me with great pride and once again demonstrates our leading role as a focused biosimilar specialist”.

In the parallel phase III study, the safety and efficacy of FYB206 will be compared with the reference product Keytruda® in patients with non-small cell lung cancer. Patients will be treated with pembrolizumab and chemotherapy for 24 months as part of a combination therapy. Recruitment is expected to start also very soon.

Following the completion of clinical development and subject to approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and 2030 for the EU.


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

[i] Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results – https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/

[ii] Word Health Organization (WHO): Global cancer burden growing, amidst mounting need for services -https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services