Biosimilar Naming Research Articles

Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective.

In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures; efforts from all involved stakeholders will be crucial. These recommendations can serve as a strategy for biosimilar adoption in other countries in a similar situation.

Assessing Knowledge and Attitude of Healthcare Professionals on Biosimilars: A National Survey for Pharmacists and Physicians in Taiwan.

Despite the first approval of biosimilars’ in 2010, biosimilar products usage has remained low in Taiwan. This cross-sectional survey study assessed healthcare professionals’ (HCPs)—hospital pharmacists, oncologists, and rheumatologists—knowledge, and attitudes toward biosimilars. More precisely, their knowledge and attitude towards biosimilars’ current usage and regulations in Taiwan were analyzed. The mean ± standard deviation knowledge score was 2.56 ± 0.86 out of 4 (n = 395), and a difference in knowledge score was determined according to the hospital types (p = 0.004). Rheumatologists possessed significantly higher confidence in their knowledge of biosimilars than other HCPs (p = 0.001). Pharmacists showed the highest acceptance—and rheumatologists the least—for switching patients from reference drugs to biosimilars (p = 0.02). Hospital type was associated with the respondent’s confidence in their knowledge (p = 0.04) and the preference for distinguishable naming of biosimilars (p = 0.007). Their knowledge scores were associated with their confidence in the efficacy and safety of biosimilars (p = 0.02). The study found that the current level of biosimilar knowledge of HCPs in Taiwan is low. The higher the knowledge score, the greater the confidence in biosimilars and the familiarity with relevant regulations.

Regulatory challenges with biosimilars: an update from 20 countries.

The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019–2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a “reliance” concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.

Science of Biosimilars.

Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity. Regulatory agencies expect these differences to be identified, analyzed, and minimized through iterative processes and extensive preclinical efforts. Generic naming of biosimilars reflects the nonproprietary reference product name along with a meaningless four-letter suffix to ensure that each product can be uniquely identified for prescribing and pharmacovigilance purposes. Labeling information for biosimilars reflects a greater detail of comparisons to reference products than conventional generic drugs, which ensures that prescribers can understand the source of information and have a complete understanding of the therapeutic profile of each biosimilar agent. Postmarketing surveillance programs will be required to evolve and ensure optimal pharmacovigilance reporting, because the potential for unexpected adverse events with biosimilars is higher than with conventional generic agents as a result of different manufacturing processes and different clinical trial designs and durations. The existing filgrastim biosimilars are likely to be joined soon by therapeutic monoclonal antibodies, including rituximab, trastuzumab, and bevacizumab, on the basis of patent expiration dates and clinical trial results.

Biosimilar Naming Conventions: Pharmacist Perceptions and Impact on Confidence in Dispensing Biologics.

The approval of the first biosimilar in the United States has placed increased pressure on the FDA to provide guidance on the naming convention that will be assigned to current and future biosimilars. The release of the FDA draft guidance on nonproprietary naming of biosimilars in August 2015 established a naming convention for all biologic products, including biosimilars. However, the draft guidance is nonbinding while the FDA continues to receive input from stakeholders, and it does not address the naming convention that will be used for products designated as interchangeable biologics. To (a) determine pharmacist perceptions of biosimilar naming conventions and their impact on confidence to dispense biosimilars and (b) measure the burden that is created by laws and regulations requiring pharmacists to complete postdispense notifications. A cross-sectional survey of 781 members of the Academy of Managed Care Pharmacy and the Hematology/Oncology Pharmacy Association was conducted using an online survey software program. Participants reported preferring a biosimilar naming convention that uses a nonproprietary base with a designated suffix (48.1%), compared with the use of a nonproprietary base alone (26.3%), nonproprietary base plus a prefix (14.2%), or a unique brand name (11.4%). However, when participants were asked to report their confidence levels when dispensing a biosimilar in place of the reference biologic, more participants reported high levels of confidence when the products shared the same nonproprietary name (62.9%). A majority of participants (64.9%) reported perceptions of increased burden when required to provide a postdispense notification to prescribers when dispensing biosimilars. According to the survey used in this study, pharmacists prefer the use of a naming convention for biosimilars that includes a nonproprietary proper name with a designated suffix; however, levels of confidence in substituting a biosimilar for the reference biologic are highest when products share the same nonproprietary name. In addition, the results of this study suggest that the naming convention and postdispense notification requirements may affect the willingness of some pharmacists to dispense interchangeable biologics. This effect will be minimized if interchangeable biologics share the same nonproprietary name as the reference biologics. Funding for this study was provided by the Academy of Managed Care Pharmacy. The author reports no conflicts of interest. Tomaszewski was responsible for all aspects of project and manuscript development.

Biosimilar naming affects confidence in dispensing

Biosimilar naming affects confidence in dispensing

Biosimilars naming: Pharmacists can provide feedback to FDA

Prescribers in the United States currently have one FDA-approved biosimilar drug available to them: filgrastim-sndz (Zarxio—Sandoz). Ten or more are in the pipeline. Before those drugs hit the market, FDA has recognized the need for clear and consistent regulations on the naming of these products. On August 28, FDA released draft guidance on the naming of biosimilars.

FDA Draft Guidance on the Naming of Biosimilars

FDA Draft Guidance on the Naming of Biosimilars

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices.

Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals. Now, with the first biosimilar approval in the USA and many biosimilars expected to be launched globally in the near future, US Food and Drug Administration (FDA) guidance on biosimilar naming conventions will be essential. To inform the FDA and the global drug development community, the Tufts Center for the Study of Drug Development (Tufts CSDD) examined primary suspect reports sent to the FDA's Adverse Event Reporting System (FAERS) from US reporters for two biologics that have lost patent exclusivity--somatropin and human insulin--and extracted 4703 insulin reports and 6487 somatropin reports from FAERS. The results show that reporting practices are inconsistent between the two biologics that were evaluated and that manufacturer identifiability and traceability are lacking. Ways to improve biosimilar naming conventions and improve reporting practices are suggested.

Assessment of pharmacists' views on biosimilar naming conventions.

As the date for the introduction of biosimilars in the United States approaches, questions remain regarding the naming, coding, and approval process for these agents that will need to be carefully considered. To (a) ascertain pharmacists' awareness of and comfort level with biosimilars and (b) determine the impact of identical or different nonproprietary names on pharmacists' confidence in substituting interchangeable biologics. The Academy of Managed Care Pharmacy, the American Pharmacists Association, and the American Society of Health-System Pharmacists fielded a survey to their membership or a partial segment of their membership. The survey consisted of 2 sections: (1) current processes for reporting biologics being dispensed and (2) familiarity and preferences regarding biosimilars. A substantial majority (70.1%) of respondents reported regularly using National Drug Code numbers as the identifier for biological products dispensed to patients; however, 10.4% of respondents reported using either the nonproprietary name or the Healthcare Common Procedure Coding System code as the identifier. When presented with 3 scenarios for naming conventions of interchangeable biosimilars and asked to rate their level of confidence (1 = not confident, 5 = very confident) to substitute, 74.6% of pharmacists indicated that they would be confident or very confident in substituting an interchangeable biosimilar with the reference product if both shared the same active ingredient or nonproprietary name of the reference biologic; 25.3% of pharmacists were confident in substituting when the nonproprietary name is not shared with the biologic; and 37.3% of pharmacists expressed confidence in substituting when the biologic and biosimilar product did not share the same nonproprietary name because of a prefix or suffix. The imminent entry of biosimilars into the U.S. market highlights the need to carefully evaluate current processes of identification, reporting, and recording of the biological products dispensed. The results of this survey indicate that the ultimate decision on the naming convention for biosimilars may influence dispensing pharmacists, with the majority of respondents being most comfortable with biosimilars having the same nonproprietary name as the reference biologic.

Debate over naming of biosimilars intensifies ahead of WHO meeting

Debate over naming of biosimilars intensifies ahead of WHO meeting

Biosimilars 101: considerations for U.S. oncologists in clinical practice.

Biosimilars of biologics used for cancer treatment and supportive care are expected to enter the U.S. market soon. Biosimilars will be highly similar to their reference products, but unlike generic drugs, not identical. Differences between a biosimilar and its reference product may arise because of the complexity of biologics, and differences in the cell lines and processes used during manufacturing. Biosimilars will be approved in the United States through a regulatory pathway based on comparative analytical and clinical studies for their characterization and demonstration of no clinically meaningful differences from their reference products. Unlike generics, initial approval may not include interchangeability, as additional evidence may be required before a biosimilar could be approved as interchangeable with its reference product; interchangeable designation could allow pharmacy-level substitution without prescriber intervention. In some cases, the U.S. Food and Drug Administration (FDA) may extrapolate an indication that has not been formally investigated for the biosimilar but that is approved for the reference product. Robust safety monitoring of all biologics is important to track and accurately attribute adverse events, particularly because their inherent complexity and manufacturing differences make them susceptible to structural changes that can affect safety (e.g., immunogenicity). Accuracy of postapproval safety reports will partly depend on the biosimilar naming approach. Potential cost savings should be evaluated in the context of differences in manufacturers' patient-assistance programs, copayments, and institutional costs. A manufacturer's ability to ensure reliable supply of high-quality biosimilars should also be considered. Broad understanding of these issues is critical for oncologists preparing for their use in clinical practice.