Congressional Testimony Calls for Action on Biosimilars

On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.

Chester (Chip) Davis Jr, president and CEO of the Association of Accessible Medicines, testified to the benefits that biosimilar and generic competition bring to the healthcare market, but said that the balance between innovation and accessibility of drugs is being threatened by reimbursement frameworks, the abuse of laws and regulations by bad actors, and the failure of policy to account for the challenges facing generics and biosimilars.

“In fact,” said Davis, “while brand drug innovation has benefited from a series of subsequent laws establishing incentives and development tools, the generic and biosimilar marketplace and patient access has not received an equivalent level of attention.”

Davis called for a repeal of the “misguided” penalty on generic drugs under Medicaid, the passage of the bipartisan CREATES Act and the FAST Generics Act, and the creation of a “level and competitive playing field” for biosimilars in Medicare. In particular, Davis pointed to the “perverse incentive for health plans and patients to use a higher-priced brand biologic” created by the structure of Medicare Part D’s coverage gap.

“This approach creates substantial barriers for biosimilar manufacturers, as it may be effectively impossible to ever offer sufficient discounts to be included on Part D formularies,” he warned, calling for an amendment to the Part D coverage gap discount program to classify biosimilars as “applicable drugs.”

Davis also took an opportunity to highlight the recent scandal surrounding Allergan’s patent transfer to the St Regis Mohawk tribe in its efforts to shield Restasis patents from inter partes review challenges, echoing FDA Commissioner Scott Gottlieb, MD, in using the term “shenanigan” to describe Allergan’s novel strategy. While Restasis is not a biologic, Davis suggested that biologics and biosimilars are subject to similar anti-competitive practices that are keeping the United States from attaining the promise of biosimilars.

Also testifying was Matt Eyles, senior executive vice president and chief operating officer of America’s Health Insurance Plans, who attested to the importance of biosimilars in the US marketplace.

“Some of the costliest and most widely-used biologics have been on the market for decades without biosimilar competition,” said Eyles. “To achieve this promise, it is important to ensure that the FDA promulgates regulations that promote a robust market and ensure providers and patients have unbiased information available to them about the benefits of biosimilars.”

Eyles called on the FDA to aim for greater clarity—and to reduce unnecessary regulatory hurdles—in its policies concerning labeling, naming, and interchangeability of biosimilars.

Additionally, Lori M. Reilly, executive vice president of policy research and membership for the Pharmaceutical Research and Manufacturers of America, testified that finalizing FDA guidance documents related to biosimilars is necessary to reduce regulatory uncertainties for biosimilar manufactures and to accelerate the market entry of these products, which Reilly estimated would account for a $38 billion erosion in sales of brand-named biologics by 2021.