Although many patients cannot afford the high cost of biologics, they question the safety & efficacy of biosimilars.
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Explore This IssueMarch 2019
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If the biosimilar passes the initial review, then the sponsor must perform at least one clinical trial that is a head-to-head comparison with the reference product. The comparability trial is designed to confirm similar efficacy and safety in a sensitive population and is based upon the null hypothesis that the biosimilar is either inferior or superior to the reference product based upon predetermined equivalence parameters. The phase 3 trial must be of a long enough duration to reflect disease state and to detect any clinically important adverse events. The results of the biosimilar and reference product trial must mirror the initial endpoints. A quick search reveals many clinical trials designed to demonstrate the efficacy of biosimilars are currently underway.
The FDA approves the biosimilar for licensure once the sponsor has demonstrated any differences between the biosimilar and the originator are not clinically or statistically meaningful for the primary endpoint. Once the sponsor has demonstrated equivalence, it can then extrapolate clinical data across the multiple indications of the reference drug. This extrapolation eliminates the very costly and time-consuming process of running phase 3 trials for each indication and population.
Despite these stringent requirements by the FDA, healthcare providers can be reluctant to try the biosimilars. This may be due to a misperception that biosimilars are the same as generics. An examination of the approval process for biosimilars, however, reveals it extends beyond that required for generics. Biosimilars must have the same mechanism of action as the originator product and be administered in the same way.
Ms. Garnoc emphasized healthcare providers have an important role in not only educating themselves about biosimilars, but also educating their patients. She pointed the audience to the “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases” published in 2018.2 The recommendations were written by an international group of 25 experts and patients. The authors reviewed 29 full text articles, as well as conference abstracts, and wrote five overarching principles and eight consensus recommendations regarding the evaluation and use of biosimilars to treat rheumatological diseases.
Lara C. Pullen, PhD, is a medical writer based in the Chicago area.
- Mulcahy AW, Hlávka JP, and Case SR. Biosimilar cost savings in the United States. 2017. Rand Corp.
- Kay J, Schoels MM, Dörner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis. 2018 Feb;77(2):165-174.