I recently had the pleasure and privilege to represent Vizient and present at a public hearing by the U.S. Food and Drug Administration (FDA), focused on removing barriers affecting the uptake of biosimilars, which offer a cost savings for some of the most expensive drugs on the market. Given the steep price for medications in our country, the importance of conversations like this cannot be overstated.
One way to combat increasing costs is through competition; competition for drugs that have been on the market for decades without an alternative, and for those whose life-saving benefits are out of reach because of their price tag. In fact, for the 10 most expensive drugs in the country, competition from biosimilars could be the solution to lowering prices.
Since 2010, Vizient has provided ongoing training and education on the biosimilar paradigm to its membership in the form of more than 200 in-person presentations and web conferences. We have also developed evidence-based clinical resources to support members in their formulary evaluations of approved and pending biosimilars, and worked with existing and future biosimilar manufacturers on contractual relationships to maximize the value and cost-savings opportunities for member hospitals.
Based upon our experience, and more importantly that of our diverse membership, we have accumulated a wealth of insight regarding the barriers biosimilar are facing. To overcome those barriers, I shared four recommendations with the FDA.
Recommendation 1: To address the continued hesitancy some clinicians still possess concerning the safety and efficacy of biosimilars in relation to their originator reference counterparts, provide increased detail around biological drug approvals.
Vizient applauds FDA’s efforts at enhancing the information available on its web site targeting clinicians, patients and the pharmaceutical industry. However, publishing the summary review documents for all biosimilar approvals, as well as the history and timing of manufacturing changes for originator biologics, would further facilitate the understanding of biosimilars at both a product-specific and global level.
I have witnessed the impact this content (or its absence) has had on the adoption of biosimilars with clinicians. While pharmacy and therapeutics committee evaluations by member hospitals of infliximab-dyyb (the first biosimilar of infliximab approved in the U.S.) were aided by the availability of the summary reviews, the consideration and acceptance of infliximab-abda (the second approved biosimilar of infliximab) has been hindered by their absence.
While availability of all biosimilar approval summary reviews would increase the acceptance of specific products, disclosure of other information about all biologics, originators included, would enhance acceptance of the biosimilar category as a whole.
One of the barriers to driving acceptance of the biosimilar concept has been the lack of familiarity of most clinicians (pharmacists and physicians) of the practice of comparability determinations for originator biologic manufacturing changes. Few practitioners are cognizant of the changes that occur throughout the lifecycle of an originator biologic and view the role of analytical characterization as something unique and novel to the biosimilarity determination experience.
Recommendation 2: Revise and expand the content provided in the Purple Book as well as increase the ease of data review and interpretation.
The FDA should replicate the functionality of the Orange Book in providing a more user-friendly, searchable database that would clearly represent the relationship between originator reference biologics and any associated biosimilar and/or interchangeable products for the Purple Book.
Other information that should also be included and easily accessible to clinicians regarding biosimilars is the extent of indication coverage as compared to the originator biologic and the impact of orphan drug exclusivity on that labeling. When searching for a biosimilar, users should quickly see to what extent a product’s label matches that of the originator reference product and what absent indications are the result of orphan drug exclusivity.
Further, the Purple Book would be an excellent place for the information noted in the first recommendation like summary review documents and originator biologic manufacturing changes.
Recommendation 3: To maximize the efficiency of approval of interchangeable biologics, finalize the interchangeability guidance and provide further clarity around the utility and relevance of the interchangeability designation.
Physicians and pharmacists are aware final guidance on this issue is still pending and that no formal trials to assess interchangeability have been completed by manufacturers. However, in addition to the absence of this information, there remains a lack of understanding regarding the usefulness of this specification.
Use of biosimilars has been, and will likely continue to be, subject to formulary management strategies, and drive by protocol prior authorization activities. As a result, substitution by a pharmacist working independently of this infrastructure is unlikely to occur. Therefore, the value of this designation remains uncertain among many clinicians.
Recommendation 4: Review the decision on the “devoid of meaning” suffix when it comes to biologic nomenclature.
Vizient continues to receive numerous comments from its membership regarding the “devoid of meaning” suffix and its utility in clinical practice. While every clinician understands the importance of pharmacovigilance, our member clinicians continue to question if the current strategy is useful or if it simply reinforces originators' claims that a biosimilar competitor ”isn't the same drug.”
Vizient and its membership endorse all relevant strategies to improve the safe, appropriate use and monitoring of all medications. We also agree that the documentation of safety and efficacy of biosimilars will eliminate some of the unnecessary hesitancy clinicians may have toward this new class of agents. We believe multiple strategies could make this process more effective and efficient.
- Option 1 - An alternative to the “devoid of meaning” suffix is the tracking and monitoring of the unique serialization requirements established in the Drug Quality and Security Act. The unique designation at a product level would enable tracking not just of a version of a biologic, but the specific lot. Given this increased level of detail, such a mechanism would provide the highest level of specificity.
- Option 2 – If the FDA considers modification of the proper name to include a separate identifier a necessary element, Vizient recommends using a meaningful differentiator to convey useful information about the product (i.e. whether it is an originator or biosimilar, whether or not it is interchangeable, the extent of indication coverage, etc.).
- Option 3 – If the FDA maintains the approach of the “devoid of meaning” suffix, Vizient recommends the application of this standard to all biologics, originators and biosimilars. This approach would address the concern that biosimilars are in some way meaningfully different from originators.
Vizient fully endorses the scientific principles of biosimilarity and the opportunity these drugs offer to mitigate the accelerating growth of pharmaceutical expenditures in our country. We will continue to work with the FDA and our members to do everything we can to make sure that we’re limiting any risk or barriers that slow their acceptance in the market.
About the author. In his role as associate vice president of pharmacy services, Steven Lucio is responsible for providing education to member organizations and supporting their efforts on various clinical practice topics, including improving medication safety, mitigating the impact of drug shortages, benchmarking pharmacy costs for key drug classes, evaluating the expense of high-cost biologics and preparing for the future development of biosimilar medications. He is lead author of a recently published peer reviewed article on biosimilars. Lucio is an active speaker and panel moderator and has presented his insight on biosimilars more than a dozen times in the past year.