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Biosimilar Headway in the US: Regulatory and Manufacturer Perspectives

May 22, 2019

On the final morning of the ISPOR annual meeting (May 22, 2019; New Orleans, LA), a panel focused on the regulatory process as well as other hurdles for biosimilar headway in the US.

The panel included Eva Temkin, JD, acting director of policy, office of therapeutic biologics and biosimilars, US Food and Drug Administration (FDA), as well as Chad Pettit, executive director and biosimilars expert, Amgen pharmaceuticals, among others.

Ms Temkin began her presentation on the regulatory considerations for biosimilars and interchangeables by stating that the FDA will continue to play a critical role in facilitating increased access to biosimilars. The FDA released a Biosimilars Action Plan in 2018 that provided information about key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars.

She noted that as of May 1, 2019, eight biosimilar products are believed to be commercially launched, 78 programs were enrolled in the Biosimilar Product Development program, and 29 351(k) submissions have been publicly announced. Ms Temkin also referenced the Biologics Price Competition and Innovation Act of 2009 that was created as an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with and FDA-licensed reference product.

In demonstrating interchangeable biosimilarity, manufacturers must ensure that the biological product is biosimilar to the reference product, that the biological product is expected to produce the same clinical result as the reference product in any given patients, and that for a product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the product and the reference product is not greater than the risk of using the reference product without such alternation or switch, she noted.

Ms Temkin then referenced the recent final guidance provided by the FDA for demonstrating interchangeability with a reference product, which outlines a stepwise approach to generate data and employs a totality-of-the-evidence approach. Furthermore, the final guidance offers a commentary on switching studies, non-US comparators, and post-marketing data.

In her concluding remarks, Ms Temkin acknowledged that an enhanced Purple Book is in development. The original Purple Book provided by the FDA offered a list of biological products licensed under the PHS Act. The enhanced Book will offer an improved interface to provide user-friendly information to the public about approved biologics, as well as enhanced information for patients, prescribers, pharmacists, and other stakeholders.

After a brief presentation on the legal challenges for biosimilar headway in the US, Mr Pettit spoke about the current situation of biosimilars launched in the US. In the past year, four products were launched and seven products have been launched since 2015. Additional, 18 molecules have been approved by the FDA as biosimilar, and over 70 molecules are undergoing approval. This “significant” boom of biosimilar approval and uptake mirrors that of Europe when biosimilar approval and uptake was in its infancy there, he noted.

He also offered a few staggering statistics around biosimilar use in the US. In 2019, it is estimated that biosimilars will save the US health care system approximately $7 billion. By 2023, the estimate grows to $60 billion. In this time span, the estimate equates to $150 billion in savings that biosimilars will bring to the marketplace, a “tremendous value,” he stated.

When concluding the session, Mr Pettit spoke about the three crucial elements to foster a robust and sustainable biosimilars marketplace over the long-term: scientifically appropriate regulatory standards that ensure safety and efficacy and strengthen stakeholder confidence, a market that encourages competition on a level playing field to achieve meaningful savings and long-term stability, and scientifically accurate educational outreach to drive uptake and proper use of biosimilars.—Zachary Bessette

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