Increasing competition in the biosimilar market is likely to be the most promising way to increase access to these expensive drugs because it is unclear if policies designed to remove barriers to entry and utilization will lead to a lower-cost biosimilar market, according to a policy forum published in the AMA Journal of Ethics.
Effective for illnesses ranging from cancer to autoimmune diseases, biologics are among the most expensive prescription drugs in the United States. In 2010, the Biologics Price Competition and Innovation Act (BPCIA) — an abbreviated approval pathway for near-identical versions of biologics (biosimilars) — was created by Congress to stimulate competition. The goal was to drive down the cost of biologics and expand access in the way that the Hatch-Waxman Act did with generic small-molecule drugs in 1984. However, as of February 2019, only 17 biosimilars have been approved by the US Food and Drug Administration (FDA), and only 7 biosimilars covering 4 originator biologics are currently available for prescription.
Overall utilization of the biosimilars on the market has been limited. This is partly because biosimilars are entering the market with only a 15% discount compared with the list price of the originators, so they are acquiring only 5% to 20% of the biologics market. The result is that biosimilars have not yet lived up to the intended goal of policymakers (ie, increasing competition and reducing patient expense).
Another barrier is the lack of commercialization and the low utilization of the biosimilars that have already been approved by the FDA. This is largely because the manufacturers of the originator biologics have used tactics to slow adoption of biosimilars, such as AbbVie’s ongoing patent litigation with adalimumab, which is the top-selling drug in the world. The patent on the active ingredient in adalimumab expired in 2016. However, AbbVie has created a “patent thicket” to protect their assets, with patents for new formulations, the manufacturing process, and other aspects of production. Most settlements from this litigation have resulted in deals that both delay entry to the market and require the manufacturers to pay AbbVie a royalty once they do reach the market.
Another strategy is to contractually obligate commercial payers to either exclude biosimilars or employ provisions that require patients to fail on the original biologic first before they can be reimbursed for a biosimilar. Manufacturers have also threatened to withhold rebates on other products if insurers do not grant exclusive use of the originator biologic. At least 70% of patients with commercial insurance are affected by these kinds of exclusionary contracts.
Limited biosimilar availability has also led to substantial skepticism as to the safety and efficacy of these products among prescribers and users. In 2016, a national survey found that 55% of physicians in specialties with high utilization of biologics did not believe that biosimilars were appropriate and safe to prescribe for their patients, and similar studies have shown them to have low awareness of biosimilars in addition to concerns about safety and efficacy. Much of this skepticism has allegedly been promoted by manufacturers of originator biologics, who mischaracterize elements of the criteria for biosimilars to imply inferiority, when studies up to this point show no clinically meaningful differences.
Proposed solutions include legislation to increase transparency in the reporting of biologic patents, scrutiny by regulatory agencies to oppose anticompetitive practices of manufacturers, and increased educational efforts on the part of the FDA to ensure physicians and patients understand the bioequivalence of biosimilars. However, some argue that skepticism about biosimilars is rooted in the BPCIA pathway not sufficiently guaranteeing their safety and efficacy, although so far, the minor structural differences between the originators and their biosimilars have not resulted in any meaningful clinical differences. Future postmarketing studies will continue to be necessary.
The most important question policymakers need to have answered is whether increased use of biosimilars will improve public health. Currently, the high cost of biologics is a barrier to patient access and adherence, and price reductions will reduce this significant barrier.
The researchers conclude that increasing competition in the biologics market through biosimilars is the most promising way to increase patient access, and they discuss the FDA’s Biosimilars Action Plan. “Recognizing the numerous barriers to the development and utilization of biosimilars, the FDA outlined 4 key goals in tackling this issue, including streamlining the approval process, improving regulatory clarity, increasing educational efforts to improve understanding among stakeholders, and collaborating with the Federal Trade Commission to address anticompetitive behaviors. Despite barriers to their commercialization and uptake, biosimilars remain a powerful tool with potential to lower health care costs and improve patients’ access to valuable therapeutics.”
Zhai MZ, Sarpatwari A, Kesselheim AS. Why are biosimilars not living up to their promise in the US? AMA J Ethics. 2019;21(3):E668-678.