Russian biotechnologies are no longer a distant future but a present-day reality, evolving into ready-made solutions for the treatment of serious diseases. These developments include monoclonal antibodies, regenerative medicine products, and mRNA vaccines. GxP News explores the potential of Russian scientific research and the success of its implementation into clinical practice.
FMBA: technological base and full production cycle
The Federal Medical-Biological Agency (FMBA) is considered one of the best-equipped research institutions in Russia. The FMBA structure includes over 300 subordinate medical organizations and about 2,500 healthcare facilities. It operates 35 research and scientific-production centers, 10 of which are engaged in fundamental research.
At the press conference “The Main Thing in Life Sciences: From Discoveries to the Implementation of National Strategy,” the head of the FMBA, Veronika Skvortsova, spoke about the developments that have emerged over the past three years. For instance, they have managed to build a full cycle from scientific research to industrial production through the introduction of standardized technological platforms based on biotechnologies such as genetic and bioengineering, peptide synthesis, molecular conjugation, and others.
“Along with striving to be self-sufficient, we also have very strong partners. If, upon completion of clinical trials, we realize that a product is promising, has demonstrated safety and high efficacy, but cannot be sufficiently replicated at the agency’s own sites, then we work with industrial partners on a seamless industrial transfer,” said Veronika Skvortsova.
This approach has shortened the innovation chain by 2.5 to 3 times and made it possible to create the products the country currently needs. In particular, over the past few years, the Ministry of Defense and other security agencies have been supplied with a line of biopathogen detectors and alarms. Simultaneously, new PCR diagnostic methods and antidotes for toxic agents were developed. Kits for radiation and chemical protection have been created, produced in pre-filled syringes and fast-acting capsules for ease of use in challenging environments.
The FMBA’s technological base enables the development of drugs and vaccines. More than 40 pharmaceutical products have been created on various biotechnological platforms, 20 of which have already been registered.
Breakthrough vaccines: from allergies to oncology
The world’s first recombinant allergy vaccine was developed by specialists at the Institute of Immunology of the FMBA of Russia, with Generium as its industrial partner. In October 2025, the second phase of clinical trials was completed, and recruitment of volunteers is currently underway for the third phase, which is expected to confirm the vaccine’s effectiveness during the flowering season in the spring of 2026. The vaccine’s uniqueness lies in the first-ever application of allergen mapping technology in its creation, which has improved tolerability and efficacy. While traditional immune desensitization required a patient to receive 30 injections, this vaccine requires only five subcutaneous injections, administered once a month from October to February.
At the end of last year, the FMBA of Russia received approval for the clinical application of an innovative personalized peptide cancer vaccine for the treatment of colorectal cancer. It is created specifically for an individual’s tumor, taking into account the genetic characteristics of the patient’s immune system. This approach allows targeting cancer cells while sparing healthy ones. According to Veronika Skvortsova, patients with this diagnosis can now apply to participate in clinical trials.
The St. Petersburg Institute of Vaccines and Sera, the FMBA’s core industrial site, is a full-cycle developer and manufacturer of therapeutic, prophylactic, and diagnostic products. It produces the first domestically developed conjugated polysaccharide vaccine against Haemophilus influenzae, and clinical trials of a 16-valent vaccine against pneumococcal infection have been completed.
The meningococcal vaccine developed by scientists at the St. Petersburg Research Institute protects against five serotypes of meningococcal infection, including the deadly serotype B. Follow-up monitoring of patients included in the phase III clinical trials is currently being completed, and vaccine registration is planned for this year.
In the second quarter of 2026, the FMBA plans to submit an application for authorization to use vaccines against glioblastoma (brain tumor). In early 2027, documents will be submitted for the use of a vaccine for uveal melanoma, which affects the eye membranes.
New drugs: from arthritis to spinal muscular atrophy
At the end of 2025, a drug was registered that became the world’s first biosimilar of canakinumab for the treatment of systemic juvenile idiopathic arthritis, gout, active adult-onset Still’s disease, and familial Mediterranean fever.
A clinical trial has been initiated for an anti-tumor drug targeting particularly severe, progressive solid tumors—of the cervix, head and neck, and breast—that are resistant to conventional therapy and cannot be surgically removed.
This year, the mandated preclinical studies of a new gene therapy drug for spinal muscular atrophy types 1 and 2 are being completed. According to Veronika Skvortsova, the new drug is not an analogue of Zolgensma, the world’s most expensive medication.
“One of the main tasks of the FMBA is not just to ensure the country’s technological sovereignty, but to achieve absolute leadership by finding solutions that offer significant advantages over existing analogues,” Skvortsova stated.
From lab to patient: challenges and prospects
Alexandr Rumyantsev, President of the National Medical Research Center for Pediatric Hematology, Oncology and Immunology and a State Duma deputy, stated that the integration of FMBA-developed vaccines into the healthcare system will most likely occur in the second quarter of this year. This means that medical care, including innovative therapy, will be provided to Russians free of charge.
Vitaly Zverev, Scientific Director of the Mechnikov Research Institute of Vaccines and Sera, emphasized the need for the rapid introduction of new vaccines but noted that not all research institutes have the opportunity to realize their scientific potential in practice.
“Today, our scientists have the most modern platforms for creating new vaccines. The only thing that is sometimes lacking is the connection between scientific organizations and the actual manufacturer,” said Vitaly Zverev.
Despite the successful experience of the FMBA, bridging the gap between the creation of laboratory prototypes and industrial production remains a pressing challenge. Science continues to advance, and the problems facing society are becoming increasingly complex. The role of effective communication between these spheres will only grow.