DIA 2023: The Future of Biosimilars, Interchangeables

With Aaron Josephson, director, regulatory policy and intelligence, Teva Pharmaceuticals, serving as the moderator, alongside Stacey Ricci, director, scientific review staff, OTBB, OND, CDER, FDA; Leah Christl, executive director, global biosimilars regulatory affairs & regulatory & R&D policy, Amgen; Marta Wosinka, visiting fellow, The Brookings Institution; and Fabrício Oliveira,head of biologic products and Advanced Therapy Medicinal Products Office, ANVISA, the group convened for a DIA panel discussion, “The Future of Biosimilars and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act.”

DIA session, “The Future of Biosimilars and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act.” June 28, 2023. DIA 2023, Boston. Image Credit: © Nicholas Saraceno.

The session was intended to identify the regulatory requirements across the globe when it comes to interchangeability—specifically if streamlined development is possible—while keeping the IRA in mind.

Has the industry reached a policy agreement for Phase III style confirmatory studies?

One question that was raised revolved around the cost of developing biosimilars: Has the industry reached a policy agreement for Phase III-style confirmatory studies? Christl noted that there has been quite a bit of progress when it comes to policy, but there are products that do not necessarily need these types of studies. Biosimilars will only evolve in complexity as biologics themselves evolve, so she felt that a blanket statement should not be an option; rather, transparency for biosimilar manufacturers is a must.

In Brazil, noted Oliveira, there have been rumblings of these kinds of studies stopping, and there is an increased flexibility for the South American country when it comes to the Phase III confirmatory studies.

When it comes to interchangeability, should utilizing other countries’ clinical evidence be valid?

In this instance, Oliveira added that it is a decision taken by the patient, and works for that particular market.

Interchangeability designation in the US market

Christl expressed that there is value of interchangeability designation in the US, as it relates to pharmacy substitution. According to Wosinka, the idea of interchangeability has been damaging to biosimilars (referencing a Johnson & Johnson Remicade lawsuit), also pointing out that a substitution of biosimilars in pharmacy is different than generics.

Patient Access

The question was raised as to what regulators are seeing in the market when it comes to regulation. In Brazil, Oliveira shared that there are currently 55 approved biosimilars, with 19 under review and 13 waiting to be reviewed; he recommended that submissions continue with an improvement of guidelines.

Just as the title of the session suggests, Christl suggested that during drug development, global harmonization—with predictability and transparency—be used.

Reference: The Future of Biosimilars and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act. June 28, 2023. DIA 2023, Boston.