Barriers to market uptake of biosimilars in the US

Abstract

Background: In the US, a new approval pathway for biosimilars has been established as part of the Aff ordable Care Act. Biosimilars are anticipated to increase treatment options and lower the growth in spending on biologicals. How the commercial prospects for biosimilars will play out in the US is uncertain. From a regulatory, approvals, and market standpoint, Europe is ahead of the US with respect to biosimilars. Lessons may be drawn from European experience. Objective: To examine challenges and opportunities with respect to market uptake of biosimilars in the US. Methods: We reviewed Medline-indexed manuscripts and grey literature published in the past fi ve years on the topics of biosimilar development and market uptake. The data collected in this review informed the development of two stakeholder surveys for payers and physicians. Main Survey Results: Almost all physicians surveyed believe that if a biosimilar is approved by the US Food and Drug Administration (FDA), the product will perform similarly to the originator biological with regard to safety and effi cacy. Most physicians say they will likely prescribe biosimilars as soon as they are approved by FDA. Additionally, the majority of physicians feel comfortable switching an existing patient from the originator biological to a biosimilar. All payer respondents intend to promote biosimilar uptake by diff erentiating between the originator biological and biosimilar through the use of formulary tiering to steer patients and physicians towards biosimilars. Most payers said they would recommend therapeutic switching of biosimilars. Seventy-fi ve per cent of payer respondents expect biosimilars to have a 15-35% price discount. Discussion: Physicians will display caution when deciding on prescribing biosimilars to existing patients. Payers will look to regulatory authority guidance for further support. To maximize cost savings, payers will likely employ formulary management tools, such as higher cost sharing for originators and lower cost sharing for biosimilars. To ensure access to and monitoring of post-marketing safety and eff ectiveness of biosimilars, payers may establish patient registries through coverage with evidence development arrangements. The expected price discount of 15-35% for biosimilars is not large. Furthermore, higher rebates on originator biologicals may be used by manufacturers as a barrier to adopting biosimilars. Therefore, biosimilar manufacturers will likely have to treat biosimilars as any other branded product. Finally, biosimilars will be subject to competition from new biologicals in the same therapeutic class, including incremental improvements to existing originators.

Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region

“…Our finding complies with international results where PubMed-indexed manuscripts and grey literature reported the acceptance of prescribing FDA-approved biosimilars by almost all physicians surveyed. These physicians also believe that the FDA-approved biosimilars have the same efficacy (effectiveness) and safety profile as the originator biological (Felix et al 2014). …”

Establishing a new marketplace for biologic therapy with biosimilar agents: importance of extrapolation of data

“…In 2010, biosimilars' overall market share in Europe was 15% and is now projected to be over 20%. 1 It is estimated that between 2007 and 2020 the use of biosimilars will result in an overall savings of between US$15.5 billion and US $43.5 billion, with most of the cost reductions focused in France, Germany, and the UK. 1 Specifically for infliximab, 33 a prevalence-based model constructed for budget impact analysis predicted a net savings of US$20 million to US$27 million in six EU countries over 3 years.…”

“…1 It is estimated that between 2007 and 2020 the use of biosimilars will result in an overall savings of between US$15.5 billion and US $43.5 billion, with most of the cost reductions focused in France, Germany, and the UK. 1 Specifically for infliximab, 33 a prevalence-based model constructed for budget impact analysis predicted a net savings of US$20 million to US$27 million in six EU countries over 3 years. If budget savings were spent on reimbursement of additional biosimilar infliximab treatment, approximately 1,200 to 1,800 more patients could be treated in the six countries within 3 years.…”

“…In 2013, biologicals comprised an annual global market of US$170 billion, with recombinant insulin, human growth hormone, erythropoietins, and various monoclonal antibodies (mAbs) among the leading categories of products. 1 The biopharmaceutical market is predicted to grow at greater than 20% annually as a result of a promising pipeline, approval for more common conditions, increased utilization, and expanded indications. 2,3 Biologic drugs are structurally complex and may have several functional domains within a single molecule.…”

“…8 The introduction of biosimilars has resulted in substantial cost savings. 1 Recently, with the approval of the first biosimilar mAb, the era of biosimilar drugs has entered a second phase.…”