Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.
Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute (ACI)’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.
Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper & Scinto, noted that the lack of biosimilar uptake within the United States, offering a seemingly low return on investment, could be due to the fact that none of the biosimilars are substitutable at the pharmacy level. “Analysts have predicted that by the end of 2018, infliximab biosimilars will only get 10% of the total infliximab market. In contrast, in Europe these biosimilars have 53% of the market.”
Concerns around interchangeable biosimilars stem from many patient groups and other industry members fearing that the substitution would be made at a pharmacy level without notification to the patient or physician and would result in a clinically different or harmful result. To pre-emptively address this concern, 44 states thus far and Puerto Rico have passed policies that cover a multitude of concerns, but largely require the notification of a physician that the substitution is being made within a timely manner.
However, Bruce Leicher, senior vice president and general counsel at Momenta Pharmaceuticals, said that there are certain changes seen in reference products throughout a manufacturing life cycle, even though these products are viewed as interchangeable. “Historically, there’s been a view that reference products are interchangeable when we go through manufacturing changes, but you will see significant differences between different lots of reference products.”
Although these changes are within a threshold, as noted by Kristan Lansbery, PhD, JD, director and patent attorney at Regeneron Pharmaceuticals, many of the quality attributes remain the same. The difficulty, she states, “is that a follow-on product can only compare to the originator's final product. The biosimilar developer has no knowledge of the originator's predetermined ranges for quality attributes, and although they can acquire the product and run tests to analyze and identify quality attributes, independently produced follow-on biologics have different qualities.”
The FDA released a draft guidance document in January 2017 around how manufacturers should demonstrate interchangeability of a product and the data that it wanted developers to submit. However, there have been many concerns and questions submitted to the FDA from industry members.
Wong discussed some concerns stakeholders have about the document, including:
According to Wong, many of the questions surrounding a biosimilar achieving interchangeability will be addressed in the finalized guidance by the FDA, “which we can look forward to seeing, hopefully, in 2019.”
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans
October 17th 2024Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.