Are Extensive Clinical Studies for Biosimilars Creating Unneeded Barriers?

Specialty Pharmacy TimesMarch/April 2014
Volume 5
Issue 2

While biosimilars could eventually offer huge cost savings for consumers, stringent testing is still needed to ensure that the biosimilar product carries the efficacy and safety of the original product, according to a new study.

The study, published March 4, 2014, in the Journal of Crohn’s and Colitis, examined biosimilarity exercises in the European Union. Study authors considered whether the benefit of biosimilars undergoing extensive testing outweighed the barriers that additional tests create by keeping biosimilars unavailable when consumers could be realizing cost relief from these drugs.

As part of the Affordable Care Act, the Biologics Price Competition and Innovation Act was established to provide an accelerated approval process for biosimilars in the United States, provided the product demonstrates no meaningful differences from the original drug. While the United States awaits the first approval of a biosimilar, Europe has already approved more than a dozen medications since passing biosimilar legislation in 2004.

“In Europe, in order to obtain marketing authorization as a biosimilar, a stepwise approach should be followed,” the authors write. “Generally this means starting with a comparison of physicochemical characteristics, followed by in vitro and (possibly) in vivo data, and finally comparative clinical studies that should be performed in the most ‘sensitive’ patient population. It should always be so that applicants provide sufficient data to support that a product is comparable to the reference product in all indications.”

In the case of analytical and nonclinical studies demonstrating sufficient similarity to the original product, the authors note that comparative clinical studies must be performed to establish safety and efficacy. While further studies are not necessarily designed to demonstrate a product’s efficacy, the follow-up can confirm that the similarity observed in prior studies will translate into comparable clinical results.

“Biosimilars are designed to be used exactly the same way as their reference products,” the authors write. “Before a biosimilar is authorized in the [European Union] all aspects that are considered relevant for its biological activity are thoroughly assessed and fall within the variation observed for the originator. Furthermore, comparable clinical efficacy, safety, and immunogenicity are established in a sensitive patient population. For such products, extrapolating the clinical safety and efficacy to all authorized indications of the reference product based on the overall evidence of comparability provided from the comparability exercise is justified.”

About the Author

Davy James is the associate editor of Specialty Pharmacy Times. He can be reached at

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