Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.
While the US maintains a special interchangeable status for biosimilars, the European Medicines Agency (EMA) had left the decisions to the member states until this week, as it released its new guidance[1] that makes biosimilars interchangeable with their reference products. I had the privilege of submitting a detailed analysis of why biosimilars should be interchangeable without requiring additional studies, switching, and alternating, as needed in the United States. This report was also published recently.[2] The focus of this publication was to convince the US Congress and the US FDA to remove the interchangeable status, as it adds to uncertainty about biosimilars. The concurrence by EMA is a game-changer as it will bring high confidence among the stakeholders who may be unsure about the safety and efficacy of biosimilars. Another publication recently concluded that interchanging from one biosimilar to another biosimilar is safe and effective.[3] This should not have been unexpected based on Plato's principle of equality that if A=B and C=A, then B=C.[4]
While interchangeability is a legislative issue in the United States as described in the Biologics Price Competition and Innovation Act (BPCIA),[5] where an approved biosimilar product is further tested using switching and interchanging to qualify the interchangeable status. The FDA can do little to remove the interchangeability, but they can award an interchangeable status without requiring the 3 cycles of switching and alternating, as they have recently done in granting such status to Cimerli, a ranibizumab biosimilar developed by Coherus Biosciences.
While this status provides a distinction to the product, it has little value since ranibizumab is not self-administered and is thus not subject to substitution. In many ways, awarding an interchangeable status based on the same data that would have resulted in the licensing as a biosimilar has done more harm—the race to get the interchangeable status for marketing purposes if there are other biosimilars available that cannot be interchangeable. In the United States, the bar will move only after amendments are made to the BPCIA, and Senators like Ben Ray Luján (D-New Mexico) are pushing for this.[6]
The giant leap that the EMA has taken comes from the simple understanding, as written by the FDA, that a biosimilar is approved with a label of having "no clinically meaningful difference with the reference product."[7] Why would switching with the reference product will make any difference? The testing studies go farther requiring multiple switching and alternating that makes little sense. None of these studies have ever failed because they cannot be based on statistical and experimental design.
Biosimilars are used interchangeably across the globe, except in the United States. It is time that Senators wake up to it and amend the BPCIA.
References
[1] Biosimilar medicines can be interchanges. EMA website. September 19, 2022. Accessed October 3, 2022. https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged
[2]Niazi SK. No two classes of biosimilars: urgent advice to the US Congress and the FDA. J Clin Pharm Ther. Published July 22, 2022. Accessed October 3, 2022. doi: 10.1111/jcpt.13743
[3] Cohen HP, Hachaichi S, Bodenmueller W, et al. Switching from one biosimilar to another biosimilar of the same reference biologic: a systematic review of studies. BioDrugs. 2022;36(5):625-637. doi: 10.1007/s40259-022-00546-6
[4] Equality. Stanford Encyclopedia of Philosophy. March 27, 2001. Updated April 26, 2021. Accessed October 3, 2022. https://plato.stanford.edu/entries/equality/
[5] H.R.3590 Patient Protection and Affordable Care Act. FDA. Accessed October 3, 2922. https://www.fda.gov/media/78946/download
[6] Luján Introduces Legislation to Reduce Animal Testing. Senator Ben Ray Luján’s website. May 20, 2022. Accessed October 3, 2022.https://www.lujan.senate.gov/newsroom/press-releases/lujan-introduces-legislation-to-reduce-animal-testing/
[7] Biosimilar and interchangeable products. FDA website. Updated October 23, 2017. Accessed October 3, 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
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.
Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone
November 26th 2024The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.