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.”
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain
April 24th 2025Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.