It was projected that by 2026, biosimilars could save up to US$150 billion in the specialty pharmaceuticals market. However, in the US, it has emerged that there are inherent barriers to market entry [1]. These obstruct greater biosimilar commercialization and uptake, making it difficult to achieve large healthcare savings that were hoped for. To date, the US Food and Drug Administration (FDA) has approved 26 biosimilars [2], yet most of these are not currently available to patients.
Researchers at the UNC Eshelman School of Pharmacy in the US, have published a policy brief that identifies the obstacles that prevent more appreciable biosimilars uptake in the US. These need to be overcome to promote competition in the biologicals market and improve access to biosimilars. The three main barriers identified are summarized below.
Payment policies disincentivize biosimilar administration
Payment policies disincentivize biosimilar administration in favour of higher-priced reference products. This means reduced substitution and uptake of biosimilars occurs. For example, under Medicare Part B, providers receive reimbursement for dispensing which is based on the average sales price of the medicine. To reduce the incentive to select a higher-priced drug, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) requires that the fixed percentage for biosimilars is based on the average sales price of the reference product rather than the biosimilar’s average sales price. This is seen as a step in a right direction, but providers still get greater reimbursement if they select reference products as their average sales prices are 15%–30% higher than those of biosimilars. This price discrepancy can prevent biosimilar substitution. In addition, private insurers are likely to look to Medicare when structuring their payment policies. The brief notes that additional policy reform is required to incentivize biosimilar administration.
Providers lack understanding of the efficacy, safety, and interchangeability of biosimilars
Evidence has revealed that providers in the US lack understanding of the efficacy, safety, and interchangeability of biosimilars. In a survey of physicians, pharmacists, and other advanced practice providers, 74% could not adequately define biosimilars, and 40% considered them to be generic drugs. This lack of knowledge is not unique to the US and needs to be improved on internationally [3]. Knowledge gaps often mean physicians are less likely to prescribe biosimilars and thus uptake is stunted. Surveyed physicians noted specifically that they required more information on safety, efficacy, and cost. As such, the brief notes that knowledge of biosimilars in the US needs to be improved to promote their uptake.
Reference product manufacturers employ anti-competitive strategies to subvert biosimilar access
It has been revealed that reference product manufacturers employ schemes to stave off competition. These tactics include rebating the costs down to the point where payers cover their product over the biosimilar, disputing the interchangeability of biosimilars, and aggressively litigating and then settling with biosimilar manufacturers in what are known as ‘pay to delay’ deals. The FDA and Federal Trade Commission (FTC) have pledged to disrupt anti-competitive behaviours but no legislation on this has yet come to pass [4].
The policy brief, prepared by Mr Jefferson Pike Jr, also outlines several proposed solutions for improving biosimilar market access [5] and provides subjective evaluation of the solution’s effectiveness, political feasibility, and cost of implementation. These solutions include doing nothing (maintain the status quo), increase provider reimbursement for biosimilars, expand provider understanding of biosimilar products through continuing education initiatives, and barring anti-competitive rebate strategies by reference product manufacturers. The brief concludes that the most effective policy to implement would be to invest in educating providers about biosimilars. As such, it states that this policy should be prioritized by legislators seeking to improve biosimilar access.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Barriers to biosimilars access in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Reports/Barriers-to-biosimilars-access-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar education gaps in oncology [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-education-gaps-in-oncology
4. GaBI Online - Generics and Biosimilars Initiative. How to support a viable US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from:
www.gabionline.net/Reports/How-to-support-a-viable-US-biosimilars-market
5. GaBI Online - Generics and Biosimilars Initiative. Solutions to US low biosimilars uptake [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from:
www.gabionline.net/Policies-Legislation/Solutions-to-US-low-biosimilars-uptake
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Source: UNC Eshelman School of Pharmacy
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