Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing
2. Materials and Methods
2.1. Questionnaire and Recruitment
3.1. Participating Physicians
3.2. Knowledge of Biosimilars and Familiarity with Their Regulation in Russia
3.3. Attitudes Towards Key Policy Issues Associated with Prescribing Biosimilars
3.4. Guiding Factors for the Use of Biosimilar Products
3.5. Issues Related to Biosimilars in Professional Environments
3.6. Need for Biosimilars Education and Preferred Educational Format
3.7. Main Characteristics of Physician Groups Based on Their Knowledge of Biosimilars
Conflicts of Interest
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|I am generally comfortable prescribing biologic drugs to my patients||57%|
|If a drug has been approved by the Russian Ministry of Health, I would offer it to my patients because I am confident it is safe and efficacious||68%|
|Biosimilars are essentially the same as generic drugs||55%|
|Usually it is difficult to obtain information on clinical efficacy and safety for a biosimilar||58%|
|Biosimilars clinical trial data should be included in labeling to guide physician and patient decisions||93%|
|Publication (transparency) of clinical trial reports for biosimilars should be mandatory||94%|
|The risk for side effects is greater with a biosimilar than for the reference product||51%|
|Biosimilars should be subject to rigorous post-marketing surveillance, including establishing efficient patient registries||98%|
|Biosimilars will have a significant impact on clinical practice in Russia for another 3–5 years||83%|
|I would feel comfortable prescribing biosimilars if I am confident in their quality, efficacy, safety, and similar immunogenicity against the reference product||91%|
|Statement||Important/Extremely Important||Selected as Being in the Three Most Important Statements|
|Studies that provide clinical immunogenicity data for the biosimilar and reference product||97%||42%|
|Studies that directly compare clinical efficacy and safety between reference products and biosimilars||96%||68%|
|Studies that show pharmacokinetic similarities between reference products and biosimilars||96%||30%|
|Inclusion in international and Russian clinical practice guidelines and standards of treatment||95%||55%|
|Studies that show chemical/physical similarities between reference products and biosimilars||89%||24%|
|Studies that compare activity with in vitro functional assays between reference products and biosimilars||87%||21%|
|Acquisition cost differences||78%||31%|
|Colleague and expert opinion||78%||8%|
|Payer decisions and requirements||69%||21%|
|Statement||Important/Extremely Important||Selected as Being in the Three Most Important Statements|
|Tracking safety events with biosimilars||99%||49%|
|Access to information on studies comparing biosimilars with reference biologics||96%||54%|
|Establish reasonable and scientifically justified approach to interchangeability and automatic substitution||93%||53%|
|Physician authority to decide on the most suitable biologic for each patient||89%||47%|
|Knowledge about biosimilars among interdisciplinary colleagues||86%||24%|
|Preparing (educating about biosimilars, which includes patients) to integrate biosimilars into clinical practice||84%||18%|
|Switching between reference biologics and biosimilars||74%||19%|
|Naming conventions for biosimilars (unique vs. same non-proprietary names)||74%||16%|
|Tender policy with preference for Russian manufacturers||54%||19%|
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Karateev, D.; Belokoneva, N. Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing. Biomolecules 2019, 9, 57. https://doi.org/10.3390/biom9020057
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. https://doi.org/10.3390/biom9020057Chicago/Turabian Style
Karateev, Dmitry, and Natalia Belokoneva. 2019. "Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing" Biomolecules 9, no. 2: 57. https://doi.org/10.3390/biom9020057