BIOСAD has completed the program of clinical trials for BCD-066, the first Russian-made darbepoetin alfa for the treatment of anemia in patients with chronic renal failure and oncological diseases. According to the plans, the Russian patients will be able to receive this long-awaited biosimilar as early as at the end of 2018.
The cost of the drug manufactured by BIOCAD will be significantly lower than the price of foreign-made darbepoetin.
The results of Phase I trials and multicenter blind comparative Phase III trials demonstrated the equivalence of darbepoetin alpha biosimilar to the reference drug in terms of all major parameters of pharmacodynamics, pharmacokinetics, efficacy, safety, and immunogenicity. The investments of BIOCAD in the development, excluding the costs of organizing the manufacturing, exceeded 400 million rubles.
“This is the world’s first biosimilar of darbepoetin, the clinical trials of which were conducted in accordance with the recommendations of the European Medicines Agency (EMA). A key indicator for the efficacy of anti-anemic therapy in Phase III trials was the ability to maintain the target hemoglobin level in patients. In this regard, BCD-066 demonstrated its therapeutic equivalence to the reference drug manufactured by Amgen,” said Roman Ivanov, Vice President R&D at BIOCAD.