Reducing the years-long wait for innovative treatments: experts discussed solutions at BIOPROM-26
What direction will Russia’s pharmaceutical industry take in the coming years? How can innovative medicines reach patients sooner? How can the industry keep pace with global manufacturers in the race to develop new oncology technologies? These and many other questions were discussed at BIOPROM-26, which brought together leading industry experts, researchers, government officials and representatives of pharmaceutical companies.
One of the key questions was what needs to be done over the next four years to increase the number of promising domestic innovations, accelerate their progress towards full-cycle industrial production and use in clinical practice, and narrow the technology gap with global industry leaders.
According to Michael Maschan, Deputy Director General for Research at the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, oncology now leads all other areas of healthcare in the number of new medicines, while the United States and China remain at the forefront of development. He noted that Russian pharmaceutical manufacturers are, on the whole, not yet focused on bringing blockbuster medicines for large patient populations to market.
Forum participants noted that Russian scientists have promising innovations, but, lacking experience of commercial success, they are often reluctant to navigate the lengthy approval process. At the same time, investors in Russian pharmaceutical companies are reluctant to take on the risks of investing in products at an early preclinical stage. This highlights the need to find ways to incentivize developers and establish mechanisms to fund infrastructure.
In publicly funded institutions, new developments all too often amount to science for science’s sake or, worse still, science for the sake of a paycheck, observed Igor Korobko, Director of the Department of Science and Innovative Healthcare Development at the Russian Ministry of Health. However, he noted that efforts in recent years have begun to change the situation: more than 40 pharmaceutical products developed by federal institutions were authorized for use during 2025 and the first half of 2026.
Russian biopharmaceutical company Petrovax Pharm shared its experience of bringing innovative medicines to market at BIOPROM-26. Throughout the 30 years since its founding, the company has maintained its focus on original, innovative products. In recent years, however, Petrovax Pharm has placed increasing emphasis on complex biologics, actively expanding its oncology and vaccine portfolios. In 2024, it launched Areima® (INN: camrelizumab), an innovative immuno-oncology medicine now manufactured through a full production cycle, with a steadily expanding range of indications. This year, Russia’s Ministry of Health approved Mentetra®, a vaccine against meningococcal infection, and Elefuza® (INN: fuzuloparib), a targeted medicine for the treatment of aggressive cancers.
“Today, Western medicines account for 65% of pharmaceutical government procurement in Russia, and their share reaches 80–85% in the high-tech medicine segment. Our task is to bring our own innovative products to market by acquiring them at Phase II or III of clinical trials. This is precisely how leading international companies operate: they acquire up to 90% of their innovative medicines from external developers. It is a risky business, but it is what enables a company to have an original medicine of its own,”
Developing an innovative medicine is only the beginning. It must undergo clinical trials, obtain marketing approval and secure market access, including inclusion in clinical guidelines, the Essential Drug List (EDL) and, ultimately, the state program guaranteeing access to free medical care. This can take three to five years, creating significant barriers to patient access and risks for the manufacturer.
Speaking at the forum, Ekaterina Priezzheva, Deputy Minister of Industry and Trade of the Russian Federation, noted that improving access to innovative medicines requires consensus between manufacturers and government bodies, including the Ministry of Industry and Trade, the Ministry of Health and the Federal Antimonopoly Service. She assured participants that the government would support initiatives by companies investing in the development of innovative medicines. She also noted that artificial intelligence can already help accelerate the journey of innovative medicines to patients, from the initial concept through approval and even manufacturing.
According to Sergey Glagolev, Deputy Minister of Health of the Russian Federation, a fast-track pathway providing for accelerated inclusion in clinical guidelines and formularies should be introduced for medicines of particular social importance, regardless of their country of origin. Both medical experts and pharmaceutical manufacturers support the idea of bringing innovations into clinical practice more quickly.
“Russian pharmaceutical companies have built modern manufacturing facilities and mastered complex technologies. A gradual shift from generics to original medicines is now underway. The next step is to bring these advances into routine healthcare more quickly. A company that has invested in development, research and manufacturing needs a transparent pathway to procurement. A fast-track pathway for innovative medicines that reduce public spending is becoming increasingly important. Today, our checkpoint inhibitor camrelizumab is the most affordable cancer immunotherapy in the country. Yet, given the regulatory barriers, it will not become available to most patients who need it until 2030–2031. Can we afford to lose this time? I hope the regulator will find an answer to this question soon,”
The next stage in the development of Russia’s pharmaceutical industry is the transition from developing its own innovative medicines to rapidly bringing them into routine healthcare. This requires not only expertise and manufacturing capacity, but also clear regulatory mechanisms that shorten the gap between the market launch of advanced technologies and patients’ actual access to them.
