The uptake of biosimilars in the US has been lower than projected. Researchers at the UNC Eshelman School of Pharmacy in the US, have published a policy brief that identifies the main barriers to biosimilars uptake in the US [1]. The brief, prepared by Jefferson Pike Jr, also highlights proposed US policies that provide solutions.
The three barriers to biosimilar access are:
• Payment policies disincentivize biosimilar administration
• Providers lack understanding of the efficacy, safety and interchangeability of biosimilars
• Reference product manufacturers employ anticompetitive strategies to subvert biosimilar access
Additional information on barriers to biosimilars access can be found here [2].
Details of the proposed policies identified in the brief are summarized below.
Maintaining the status quo
With no policy changes, biosimilars uptake is likely to remain low. With time, the public may become more familiar with biosimilars and clinicians more comfortable prescribing them, which will increase uptake. This would be slow, passive uptake increase. Under the status quo, nearly two thirds of the 26 approved biosimilar products have failed to launch and in May 2020 it was reported that only two of these products were available on the market [2]. The market share for biosimilars is far greater in other regions of the world such as Europe [3]. It is evident that the current policy options are not effective.
Increase provider reimbursement for biosimilars
Increasing reimbursement for biosimilars could increase their uptake. At present, for biosimilars, healthcare providers are incentivized to choose reference products over biosimilars. Policy change to level-out the reimbursement would make low-cost biosimilars more attractive. It would create pressure on all manufacturers to reduce biological drug prices. This approach would also be in line with how brand-name and generic drugs are currently reimbursed and has great potential to improve prescribing rates of biosimilars. The brief notes that, this policy may be difficult to enact as reference product manufacturers have considerable lobbying power to oppose such legislation. It would also require significant implementation costs.
Expand provider understanding of biosimilar products through continuing education initiatives
There is a large gap in physician and healthcare provider education and awareness of biosimilars and their efficacy, safety and interchangeability. Expanding provider understanding of biosimilar products through continuing education initiatives is needed. One solution to this is to pass legislation to create a government-sponsored informational website for biosimilars and mandate biosimilar continuing education programmes. The brief notes that this policy is feasible as it does not impact the reimbursement of stakeholders and should be cheap to implement. Stakeholders and legislators should support the educational initiative that such a policy presents.
Bar anti-competitive rebate strategies by reference product manufacturers
Anti-competitive rebates negotiated by reference product manufacturers for exclusive market access are commonplace in the US market. It has been proposed that there should be removal of the ‘Safe Harbour’ protection from the federal anti-kickback statute that allows rebating of reference products once a biosimilar competitor has launched. This would remove biosimilar market entry contractual barriers and make them much easier to commercialize. The brief notes that, in terms of cost, it would take considerable funding to enforce this new legislation, but otherwise, implementation cost should be low. However, it highlights that the government may face expensive litigation from lobbyists should such a policy move forward.
Recommendations
The brief’s evaluation of these possible policies highlights educating providers about biosimilars is the most viable policy option. As such, it states that this policy should be prioritized by legislators seeking to improve biosimilar access. This policy option strikes the balance of effectiveness, feasibility and cost. The brief’s top recommendation for improving biosimilar market access is the Advancing Education on Biosimilars Act introduced in 2019.
In addition, the brief noted that all policy options will improve upon the status quo. It is also highlighted that the policy options are not mutually exclusive and ultimately, a variety of policy reforms will be needed to effectively stimulate biosimilar uptake in the US.
Related articles
Low levels of biosimilar uptake in Canada
How to support a viable US biosimilars market
References
1. GaBI Online - Generics and Biosimilars Initiative. US policy brief identifies barriers to biosimilars uptake [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Policies-Legislation/US-policy-brief-identifies-barriers-to-biosimilars-uptake
2. GaBI Online - Generics and Biosimilars Initiative. Barriers to biosimilars access in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Reports/Barriers-to-biosimilars-access-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. How to make biological drugs more affordable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/Research/How-to-make-biological-drugs-more-affordable
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