The Roles of Congress and Physician Training in the Biosimilar Market

Christopher Mikson, MD, JD, is a partner in Mayer Brown's Washington, DC office, where he serves as leader of the firm’s FDA Regulatory practice and coleader of the healthcare practice. He focuses his practice on FDA regulatory matters and complex litigation and transactional matters in healthcare and the life sciences.
October 14, 2019
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, commonly known as Hatch-Waxman, which created an abbreviated new drug approval (ANDA) pathway and a streamlined patent litigation procedure for generic drugs. The new law effectively created the generic drug industry, which substantially lowered drug prices while maintaining incentives for innovation. But Hatch-Waxman applies only to small-molecule drugs, not biological drugs. In 2010, Congress enacted the Biologics Prince Competition and Innovation Act (BPCIA), a Hatch-Waxman–like law for biologics inspired by existing biosimilar laws in Europe and elsewhere.

The BPCIA created an abbreviated biologic approval pathway and a unique patent litigation procedure for biosimilars. Due to the complexity of biologics, the biosimilar pathway is necessarily more burdensome than the ANDA pathway. The BPCIA patent litigation scheme— dubbed the “patent dance” by practitioners of the law—is infamous for its unwieldiness. Perhaps most importantly, unlike an ANDA-approved drug, a biosimilar is not considered a “generic” and therefore may not be substituted at the pharmacy under state law. The BPCIA included an additional, higher-tier category of product referred to as an “interchangeable” that would qualify for such substitution. But due to the heightened requirements for approval of interchangeables, the interchangeable pathway is not expected to yield a significant level of approvals any time soon, and so the focus has remained on biosimilars.

Despite initial optimism that the BPCIA would achieve for biosimilars what Hatch-Waxman did for generics, the results have been disappointing. In the 10 years since the enactment of the BPCIA, only a handful of biosimilars have been approved, and even fewer have made it to market, due in part to protracted patent dance litigation. 

Few realistically expected the 80%-85% price reductions realized by Hatch-Waxman, but many hoped for results comparable to the EU, where biosimilars have yielded price reductions of up to 30%-40%. Thus, some view the BPCIA as a failure, and regulators and stakeholders alike are questioning what can be done to improve on this performance. Legislation has been introduced in Congress to address a variety of discrete issues thought to affect access and pricing, including bills requiring the provision of samples to generic and biosimilar developers, compelling CMS to lower drug prices by negotiating with industry for products covered under Medicare, eliminating pay-for-delay settlements, and allowing importation of drugs from Canada.

In August, a pair of opinion pieces appeared days apart in the Wall Street Journal on this issue. Peter Bach, MD, of Memorial Sloan-Kettering Cancer Center, and Mark Trusheim, MS, of the Massachusetts Institute of Technology’s Center for Biomedical Innovation and Sloan School of Management, argued that it is “time to throw in the towel” on the biosimilar pathway.

In contrast, former FDA commissioner and current Pfizer board member, Scott Gottlieb, MD, advocated “don’t give up on biosimilars” and argued that laws of the type that have been proposed would increase competition and thereby improve the plight of biosimilars. He also suggested that improving physician education about biosimilars would be effective, an insight that is not surprising coming from him given his experience as a practicing physician.

Overall, judging success by comparing results in Europe under one-payer reimbursement systems with those under the mosaic US system of private and public payer would be illusory and unrealistic unless and until the US moves to a single-payer system, if ever. However, laws that would streamline development (easing procurement of samples), reduce government costs (CMS negotiating Medicare Part D purchase pricing), and referee the dealings between branded and biosimilar manufacturers (pay-for-delay settlements), could have incremental effects in improving access and lower pricing. 

Of the various measures proposed thus far by Congress and those advocated by Gottlieb, one area that could have a significant across-the-board effect but that has received relatively scant attention is the need for significant improvements in education and adoption by health care providers. 

Indeed, the American Medical Association (AMA), the largest representative association of practicing physicians in the United States, has discussed how this single issue is a significant hurdle for access to lower-priced biosimilars. In its August 2019 Policy Forum article entitled “Why Are Biosimilars Not Living Up to Their Promise in the US?” authors writing in the AMA Journal of Ethics discussed reimbursement conditions and measures such as curtailing rebates and pay-for-delay deals, but emphasized that “there remains substantial skepticism among prescribers and users relating to the efficacy and safety of biosimilars.”1 The piece cited a 2016 national survey that found that more than half of US physicians in specialties that use biologics did not believe that biosimilars were safe and appropriate for use in patients. The piece cited additional studies showing that patients have low levels of awareness of biosimilars as well as concerns about inadequate efficacy and elevated safety risks of biosimilars that are not consistent with reassuring evidence about their clinical usefulness.

Physician training could have a significant effect on utilization and adoption, while being susceptible to meaningful improvement through relatively modest measures. While Congress continues to work incrementally on other issues that also may be effective, lawmakers could be formulating legislation that fosters increased physician education. The subject could be more heavily emphasized in medical training throughout one’s medical career. Medical schools and residency programs are largely funded by the federal government, and they could be incentivized to increase teaching of this subject to medical students and residents. In conjunction with such measures, the United States Medical Licensing Examination could be incentivized to proffer board questions on Steps 1, 2, and 3 on the subject of biosimilars. Similarly, physician specialty board certification examinations could include this subject in their ongoing examinations administered to physicians throughout their careers. 
As noted by Gottlieb and by the AMA, encouraging increased competition in the biologics market with biosimilars remains the most promising mechanism to increase access. One way to foster this goal is to equip our physicians with the tools they need to make the most informed, evidence-based clinical decisions possible for their patients, including on the issue of biosimilars.

Reference
1. Zhai MZ, Sarpatwari A, Kesselheim AS. Why are biosimilars not living up to their promise in the US? AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668.

 

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