House Committee Hearing Calls for More Clarity on Policies Facilitating Biosimilar Uptake

Last week, The House Energy & Commerce Committee’s Subcommittee on Health held a hearing examining the Biologics Price Competition and Innovation Act (BPCIA)’s implementation in our healthcare system – an important issue that affects many Americans. The hearing featured insight from Janet Woodcock, the director of the Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), and Sean Cavanaugh, the Deputy Administrator and Director of the Center for Medicare and Medicaid Services (CMS)’s Center for Medicare.

Enacted in 2010, the BPCIA was designed to be an abbreviated pathway for biosimilar approval in the U.S. In support of this, the Biosimilars User Fee Act (BsUFA) was enacted in 2012 to expedite the review of biosimilars. However, even with these pathways in place, there has only been one biosimilar approved for patient use in the U.S. in the past five years. At this pace, it is safe to say that our biosimilar market is growing far too slowly. We need sound policies established by FDA and CMS that encourage widespread adoption to allow increased patient access to lifesaving treatments at lower costs.

Prescription drug prices continue to rise faster than inflation to the point where they are unaffordable for many U.S. patients. Now more than ever, biosimilars need to be part of the solution. Defined by the FDA as having “no clinically meaningful” differences from their reference products, biosimilars are safe, effective, and affordable alternatives to costly biologic drugs. They have been used in geographies outside the U.S. for years—Europe has used them for more than a decade, has more than 20 biosimilar drugs approved, and is enjoying significantly improved patient access and healthcare savings as a result. Enacting policies that facilitate their entry into the U.S. market would relieve the burden that is placed on our current healthcare costs by increasing competition while providing thousands of patients with access to life-saving therapies.

We agree with the Subcommittee’s sentiments from Thursday’s hearing that the FDA needs to publish additional guidance to ensure that the 60 biosimilar applications currently in its pipeline see timely approval, particularly with regard to naming, labeling, and interchangeability. The FDA should learn from Europe’s more than a decade of experience and assign the same INN to biosimilars as to their reference product. A robust biosimilars market supported by clear, comprehensive FDA guidance in the U.S. could lessen the burden of our healthcare costs while simultaneously providing thousands of patients access to life-saving treatments.

We also share the Subcommittee’s sentiment about CMS’ current reimbursement policy for biosimilars, and encourage them to review it in such a way that it doesn’t stifle the emerging market. More specifically, we believe each biosimilar product should have an individual Healthcare Common Procedure Coding System (HCPCS) code, which is in accordance with the Biologics Price Competition and Innovation Act.

We hope the FDA and CMS use the feedback gathered from this hearing to enact policies that best ensure biosimilar uptake, and we applaud the Subcommittee for holding a productive, thoughtful hearing on the subject.

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Pfenex’s full statement on Thursday’s hearing is below:

Pfenex applauds the House Energy & Commerce Committee’s Subcommittee on Health for holding a hearing to ensure the implementation of the Biologics Price Competition and Innovation Act (BPCIA). As discussed in the hearing, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) must create policies that support a strong biosimilar market in the U.S.

Since the implementation of the BPCIA in 2010, there has only been one biosimilar approved in the U.S. As prescription drug prices continue to rise—a recent survey of 3,000 prescription drugs finding numerous branded drugs have more than quadrupled in cost since 2014—biosimilars are needed now more than ever. They are more affordable than and equally as effective as biologic drugs; they have the potential to save our healthcare system billions of dollars, and they increase patient access to life-saving therapies. Additionally, biosimilars allow more resources to be devoted to new drug innovations. Pfenex applauds the Committee members for using Thursday’s hearing as a forum to encourage the FDA to release much-needed guidance on interchangeability. Such guidance is critical to encouraging new entrants into the biosimilar market and is expected to create a robust, competitive industry for biosimilars in the U.S. It is imperative that all parties work together to address these key policy questions and enact sound policies that encourage widespread adoption. We hope the FDA and CMS use the feedback received to enact such policies in the coming year.