Juliana Reed, MS: Enhancing Efficiency and Global Consistency in Biosimilar Development

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Several key initiatives designed to streamline and enhance the efficiency of biosimilar development in the US market are underway, underscoring the timeliness of the Biosimilars Forum's recent report.

A peer-reviewed report, “Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective” was recently published by the Biosimilars Forum. In the second part of an interview with HCPLive Rheumatology, Juliana Reed, MS, executive director of the Biosimilars Forum, discusses her team’s efforts to streamline and enhance the efficiency of biosimilar development in the US market.

Several key initiatives are underway, underscoring the timeliness of the Biosimilars Forum's decision to publish the paper. These include the US Food and Drug Administration (FDA)'s upcoming 4-day virtual workshop in September, which will delve into the international streamlined development of biosimilars.

“This aligns with our belief that harmonizing regulatory standards will eliminate unnecessary redundancies, thereby curbing development costs,” Reed explains. “Additionally, a consistent approach will ensure that biosimilars meet the highest scientific standards, embodying the latest understanding and technological advancements. This is a critical aspect of our endeavor.”

She also mentions how immunogenicity assessments should be approached and notes immunogenicity was a legitimate concern during the early stages of biosimilar development due to the uncertainties surrounding the profiles of biosimilars.

“However, with over 2 billion patient days' worth of experience globally involving biosimilars approved in rigorously regulated nations, no signs of immunogenicity have emerged,” Reed stated. “This suggests concerns regarding immunogenicity have been effectively addressed. It has become evident the safety and clinical efficacy profiles of biosimilars are comparable to their reference counterparts.”

As a result, Reed suggests transition to a risk-based approach for this assessment.

Another reassessment involved the interchangeable designation given to certain biosimilars.

“Drawing from 15 years of global experience and a strong safety track record, our perspective on the interchangeable designation has evolved,” she explained. “Initially introduced with biosimilars in mind, it catered to transitioning patients from a reference biologic to a biosimilar, and then to another biosimilar. However, our market observations worldwide have demonstrated seamless transitions from reference to one biosimilar and subsequently to another, with no adverse events or safety signals.”

Given this evidence, reevaluation is in order as the absence of safety or quality concerns confirm the belief patients can confidently rely on biosimilars.

This transcript was edited for clarity.