Even as developers begin work on the next wave of cost-saving biosimilars, and though approximately 50 biosimilar products (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for biosimilars.
This week Russian biosimilar developer Biocad announced that it has begun clinical studies for its biosimilar eculizumab candidate referencing Soliris, the most expensive orphan drug in Russia.
The study of the eculizumab biosimilar in patients with paroxysmal nocturnal hemoglobinuria, marking a foray into ultra-rare diseases, is a new direction for the Russian biosimilar developer; thus far, Biocad has focused on the development of widely used biosimilars, such as filgrastim, bevacizumab, trastuzumab, infliximab, and adalimumab.
Yet, even as developers begin work on this next wave of cost-saving biosimilars, and though approximately 50 biosimilar products (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for biosimilars. Some products have been authorized under an approach similar to the one used for small-molecule generics, and some following comparative clinical trials versus their reference products. Furthermore, some products have entered the Russian market with only limited clinical data available (one filgrastim biosimilar, for example, was approved on the basis of 2 small studies in a total of 51 patients).
Russia also has unique challenges in using biosimilars because of its prescribing regulations; approved biosimilars are considered interchangeable based on a demonstration of biosimilarity, and because prescribing takes place on the basis of international nonproprietary names (INNs) rather than brand names, a patient may undergo unintended switching multiple times, posing challenges for traceability and pharmacovigilance.
There are also few data available about provider attitudes toward and education about these products, but one recent study, published in Biomolecules, sought to address that knowledge gap. The authors of the study surveyed 206 providers: 51 rheumatologists, 53 gastroenterologists, 50 hematologists, and 52 oncologists.
Of the respondents, 46% were able to correctly identify biosimilars as products that are highly similar to their references. However, in response to a separate question, 37% said that biosimilars were the same as generics. Nearly all respondents (94%) said they needed greater education on biosimilars.
In total, 46% said they were familiar or very familiar with the approval process and regulations for biosimilars, and 66% said they had positive views of biosimilars. Additionally, 91% said that they would be comfortable treating patients with a biosimilar if a well-designed clinical trial had demonstrated equivalent safety and efficacy.
In total, 51% were concerned that the risk of adverse events was higher for biosimilars, 94% called for publication of clinical study reports for biosimilars, and 98% said biosimilars should have rigorous postmarketing surveillance.
Overall, 53% of respondents had a positive view of the country’s approach to interchangeability, and many cited increased access as a reason for their positive perspective. However, 53% had a negative view of pharmacy-level substitution, citing the right of the physician to choose the most appropriate treatment for the patient. Similarly, 64% supported prescribing biologics and biosimilars by brand name rather than by INN, citing the need for traceability and a desire to avoid unintended switching among products.
According to the authors, this first attempt to survey the knowledge and attitudes of Russian providers reveals a high unmet need for education. “Current physician attitudes towards, and perceptions of, biosimilars can inform future educational initiatives and highlight important issues for payers, policymakers and other stakeholders, to shape balanced and evidence-based policies for biologic medicines in Russia,” they write.
Karateev D, Belokoneva N. Evaluation of physicians’ knowledge and attitudes towards biosimilars in Russia and issues associated with their prescribing. Biomolecules. 2019;9(2): 57. doi: 10.3390/biom9020057.