Policy Experts Weigh in on Market Access Challenges for Biosimilars

At the 2017 AAM Biosimilars Council Conference, policy experts addressed the question of how biosimilar developers can navigate the complex and challenging biologics marketplace in the United States.

Elizabeth Jex, attorney advisor in the office of policy planning for the Federal Trade Commission (FTC), moderated the panel discussion, titled “Market Access, Market Success,” which included presentations by Rachel Sher, deputy general counsel of the Association for Accessible Medicines; Crystal Kuntz, vice president of policy and regulatory affairs for America’s Health Insurance Plans; and Andrew Mulcahy, policy researchers and associate research department director of the RAND Corporation.

Jex, who noted that she was speaking as an individual rather than on behalf of the FTC, opened the discussion by saying that she was concerned that anti-competitive conduct, as well as challenges in the reimbursement system for biosimilars are—in stark contrast to the European experience—“chilling price competition” for biologic therapies in the United States.

During the discussion, several key themes emerged:

Access to Samples

The panelists shared concerns that Risk Evaluation and Mitigation Strategies (REMS)—programs to manage potential risks of a drug—are being abused to withhold samples for testing. Under REMS programs, some biologics sponsors decline to provide samples of their products to biosimilar developers for testing, effectively erecting a barrier to biosimilar development.

“This is not at all what congress intended when it put the REMS authorities in place,” said Sher, noting that, even when the FDA does not require REMS for a drug, some reference product sponsors institute their own safety programs. When implemented, such programs can also restrict biosimilar developers’ access to samples.

Such strategies pose a serious risk to biosimilar developers; because biosimilar development is likely to involve a great number of samples in clinical trials; a study could fail if a developer is unable access the reference drug. “The situation with biosimilars is likely to be worse, going forward,” Sher said. For reference product sponsors, “the financial incentives in the biologics area are just so great that every day on the market without a biosimilar present is going to be worth it” to delay biosimilar entry.

Patent Litigation

The panelists expressed concerns that patent litigation has slowed the entry of biosimilar products in the US marketplace. Kuntz said that her organization filed an amicus brief last year in the case of Sandoz v Amgen with respect to delays caused by a 180-day waiting period to market a drug after a biosimilar developer provided notice of commercial marketing.

“This is an area of strong need,” said Kuntz. “We have very high-cost biologic drugs, and that’s an ongoing concern for our health plans. We wholeheartedly agree with the need to get [biosimilars] on the markets.”

While the Supreme Court’s ruling in Sandoz v Amgen has eliminated the 180-day waiting period, new concerns about inter partes review (IPR) loom for the industry; IPRs, proceedings before the Patent Trial and Appeal Board that provide for the review of patentability for 1 or more claims of a patent, have recently come under fire. According to Sher, some advocates for reference product sponsors have called for pharmaceutical patents to be exempt from IPRs.

Sher, who called IPRs both more efficient than traditional district court litigation in patent disputes and also subject to less judicial review after a decision, said that preserving the IPR process will be critical to clearing the way for biosimilar products to enter the marketplace.

Policymakers and Legislative Solutions

Educating policymakers about biosimilars and the problem of high drug costs also poses challenges, said the panelists. According to Kuntz, when engaging with policymakers, “there’s still a perception that high-cost drug issues are one-off, unique drug issues. We have to continually emphasize that this is a problem across drug classes. It’s not the exception, it’s the rule.”

Mulcahy agreed that policy makers need more education about biosimilars, saying, “even for policymakers who are really engaged and steeped in these issues, you get in the weeds pretty quickly.” With respect to biosimilars and the challenge of market access, “There’s this urge to equate biosimilars and traditional generic drugs, and I think that’s a potential pitfall…there may be some analogues, maybe some lessons learned, but there maybe aren’t that many.”

Sher saw promise in the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), which offers some potential solutions to the problems facing biosimilars. Under the Act, if a contract of sale for testing of drug samples is not finalized within a set period, generic and biosimilar developers will be able to seek injunctive relief in court, and the FDA would receive greater authority to waive the requirement for a single, shared REMS system when appropriate. The bill, she said, could remove the incentive for reference product sponors to withould samples.

As for whether the Act could succeed in congress, “we are seeing an incredible bipartisan push,” said Sher. “It has a lot of political momentum at a time when bipartisanship is not all that common.”