A Russian pharmaceutical company, Biocad, has initiated legal action against Sergei Glagolev, who serves as the Deputy Head of the Ministry of Health. The dispute appeared before an arbitration court, where prosecutors and representatives debated the case across four days within the first instance. The proceedings were reported in arbitration records, highlighting a regulatory friction between Biocad and the ministry involved in the approval pathways for medically essential products.
Biocad indicated to Forbes that the ministry official’s inaction stalled the company from placing its treatments for multiple sclerosis on the government list of vital and essential medicines that fund high-cost medical needs. This list, often referred to as the VED, is a critical mechanism for ensuring access to therapies for patients facing serious, costly conditions. Biocad argues that timely consideration by the appropriate commission could have broadened patient access to these therapies and supported the company in competing on a level playing field with other manufacturers.
As part of its strategy, Biocad is seeking a formal meeting with the departmental commission to review the potential inclusion of its multiple sclerosis treatments in the vital and essential medicines program under the 14 high-cost nosology category. The company emphasizes that a recent absence of a scheduled commission meeting, the last one having occurred in February 2023, effectively froze the evaluation process. Biocad asserts that this delay handicapped its ability to pursue equal economic competition with foreign manufacturers who also vie for inclusion in the program.
In the broader context, Biocad has been advancing its portfolio through additional development efforts, including the registration of a biosimilar for an oncology drug. This step reflects the company’s broader ambition to expand access to affordable, high-quality biologic therapies in a market that seeks to balance innovation with patient affordability and regulatory oversight. The regulatory landscape for biosimilars often involves rigorous demonstration of similarity to reference products, robust clinical data, and ongoing pharmacovigilance to ensure safety and effectiveness for patients in need.
Meanwhile, previous statements from the Ministry of Health have touched on potential threats identified within the national disease landscape, including the so-called disease X, which has been cited in policy discussions about preparedness and response. The interplay between regulatory decision-making, drug approval timelines, and patient access remains a focal point for industry observers and policy makers alike, as stakeholders assess how best to align scientific advances with public health priorities in a transparent and timely manner.
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