FYB206
Pembrolizumab Biosimilar Candidate
FYB206 is a biosimilar candidate for Keytruda® (pembrolizumab). Keytruda®* is used in cancer immunotherapy for the treatment of various tumor diseases.
Development Progress
Indication Area
Immuno-Oncology
Active Ingredient Group
PD1 Inhibitor
Indications of the Reference Drug
Advanced melanoma, Non-small cell bronchial carcinoma, Hodgkin’s lymphoma, Urothelial carcinomas, Tumors in the head and neck area, other tumor diseases*
Business Modell:
100 % Formycon Project
Market Launch
in the United States and the EU after loss of exclusivity of the reference drug
Pembrolizumab Market
its broad range of indications in oncology and sales of $31.7 billion in 2025, Keytruda® is one of the world’s best-selling drugs.
Commercialization partners:
Region: U.S. / Canada
Region: MENA
Region: APAC
provided by the EMA or FDA.
FYB206 Biosimilar Development
FYB206 Biosimilar Development
How does Pembrolizumab work?
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 supports the immune system in activating the body's own cellular anti-tumor immune response and - for example - killing melanoma cells.
February 2026
Dahlia PK study demonstrates pharmacokinetic equivalence with the reference drug Keytruda®
[Further Information]
February 2026
Lotus Pharmaceutical becomes commercialization partner for major parts of the APAC region
[Further Information]
December 2025
Zydus becomes commercialization partner for the U.S. and Canada
[Further Information]
December 2025
MS Pharma becomes commercialization partner for the MENA region
[Further Information]
July 2025
Formycon successfully completes patient enrollment for the clinical development
[Further Information]
February 2025
Based on the stringent study design and comprehensive analytical data demonstrating high structural and functional comparability with the reference drug, Formycon has agreed with the FDA on a streamlined clinical development program that does not require a Phase III study.
October 2024
Formycon publishes results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D
[Further Information]
June 2024
Start of Clinical Development
[Further Information]
September 2022
Formycon discloses the reference drug for biosimilar candidate FYB206
[Further Information]
Preclinical data
Analytical study on the comparability of the biosimilar candidate FYB206 with Keytruda®
Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
