2022 has been difficult for many patients due to the departure of foreign pharmaceutical companies and the closure of some clinical trials. This was a real challenge for the Russian healthcare system. However, domestic pharmaceutical companies found a solution. Now Russia has its own innovative developments and original drugs for the treatment of oncological diseases, and also has successful experience in launching generic drugs that have the same active substances as the original drug and whose effectiveness has been proven in clinical studies.
Thus, Russian scientists managed to create a bioanalogue of pembrolizumab (trade name Pembroria®), one of the most popular oncology drugs. It is used to treat a wide variety of cancers, including melanoma, lung cancer, renal cell cancer, and others.
Quality control
Biosimilars are generic biological products. Often the concept of “biosimilars” is confused with “generics”, which are essentially generic drugs. However, these are still different types of drugs and distinctions need to be made between them. Biosimilars are produced from a natural biological source, which is a complex, time-consuming and expensive process. Generics contain as active ingredients low molecular weight compounds that can be relatively easily reproduced by chemical synthesis methods. This is exactly the main difference between them.
Registration requirements for biosimilar drugs, unlike generic drugs, involve a series of costly and time-consuming comparative tests. At all stages of clinical development, the safety of unregistered generic medicinal products is evaluated.
BIOCAD conducted a wide range of studies in developing the biosimilar of pembrolizumab, including examining the drug’s pharmacokinetics, pharmacodynamics, safety and immunogenicity. Studies showed similar results for original and biosimilar drugs; which is pembrolizumab BIOCAD and Merck & Co. Inc. (MSD) allowed us to prove the equivalence of the original drug.
After the product is licensed and launched on the market, BIOCAD continues to obtain and collect information about the safety and effectiveness of the drug. Pharmacovigilance service operates continuously in accordance with Russian legislation and international standards.
drug independence
The emergence of a domestic biosimilar not only makes it possible to provide the necessary drug to all patients regardless of external sources, but also can reduce the cost of treatment for cancer patients. During the year of its existence on the market, this drug has managed to prove itself favorably in clinical practice. It is important that patients who were previously treated with a foreign drug now have the opportunity to switch to a Russian biosimilar, which is not inferior to the original in its properties.
Currently, BIOCAD has initiated and is conducting REFLECTION, a non-interventional retrospective study. Its task is to evaluate the safety of patients with advanced forms of malignant neoplasms of various localizations during the transition from the original drug to pembrolizumab bianolog. The effectiveness of the biosimilar is also being evaluated in patients treated for six months or longer.
During the study, a retrospective analysis of the electronic disease database of approximately 400 cancer patients across Russia was carried out. All were treated with the original drug (at least two injections were given) and replaced with the biosimilar drug (also at least two injections were given).
Study results showed that the majority of patients (98% of the group) did not experience an increase in the frequency or severity of adverse reactions. And their overall frequency did not exceed the rates observed when using the original drug. The majority of patients (88%) maintained disease control.
These transitional efficacy and safety indicators suggest that the Russian biosimilar of pembrolizumab may occupy an important place in cancer treatment.
A similar study is being carried out at the Moscow Scientific Research Center named after him. Under the guidance of AS Loginov, Doctor of Medical Sciences, Corresponding Member of the Russian Academy of Sciences and Deputy Director of the Moscow Scientific Center named after him. LIKE. Loginov on oncology by Lyudmila Zhukova. 114 patients with common forms of malignant neoplasms of various localizations participated in it. Based on the analysis results, it was possible to prove the comparability of the safety profiles of the original drug and the biosimilar. Additionally, no increase in the number or severity of adverse reactions was observed during the switch.
“At the time of data collection, the majority of patients were continuing Pembroria® treatment and disease control was ongoing. None of the patients experienced new immune-mediated adverse reactions that were beyond the scope of the medical instructions for use. Zhukova noted that there were no cases of biosimilar cancellation due to adverse reactions.
Now BIOCAD produces all medicines in Russia, including the synthesis of pharmaceutical substances, fully ensuring the continuity of drug therapy for Russian patients. This helps ensure the availability of medicines in the future.
medical supervision
Post-marketing studies of drugs are conducted after they are introduced to the market to obtain additional data on their effectiveness, safety, and side effects under real-world conditions. It allows for broader and longer-term follow-up of patients and evaluation of the effect of the drug on patients with various comorbidities.
To expand the evidence base and obtain additional data on the use of the biosimilar pembrolizumab in real-world clinical applications, BIOCAD initiated a prospective study called PERFECTION. This multicenter study aims to evaluate the effectiveness and safety of the drug in patients with advanced cancer in various regions. More than 160 patients currently diagnosed with metastatic non-small cell lung cancer, metastatic or unresectable recurrent head and neck squamous cell carcinoma, locally advanced or metastatic urothelial cancer, advanced renal cell carcinoma, metastatic or recurrent cervical cancer were included in the study. and advanced endometrial cancer.
Interim data presented from the non-interventional study noted no significant difference in the safety profile of the biosimilar pembrolizumab compared to the original drug. There were no differences in the nature or frequency of adverse reactions, including serious ones.
Studies on all the mentioned studies are ongoing, and the publication of the results is planned for 2024. Such studies are extremely important for both the medical community and the patient community. Russian medicines are in no way inferior, and in some cases even superior to foreign developments, and this can be seen from the results of using our drugs in real clinical practice.