American College of Rheumatology (02/01/15)

The American College of Rheumatology (ACR) recently released a position statement regarding the use of biosimilars, an alternative to innovator biologics. A product can currently be considered biosimilar to a reference product if data from analytical studies, animal studies, and a clinical study show that the product is "highly similar" to the reference product, and if there are no clinically meaningful differences in safety, purity, and potency. The ACR position on biosimilars for patients with rheumatic diseases is that safety and efficacy must be established in human subjects in comparison to another established agent in the same class. Studies for one indication do not necessarily prove that a biosimilar is safe and effective for other indications for which the reference biologic was approved. ACR also notes that easily distinguishable naming of biosimilars will help avoid errors in prescribing and promote pharmacovigilance. Cost may be an issue for biosimilars, and it is important to pursue cost savings when possible; but the approval process for biosimilars must make safety and efficacy, supported by scientific evidence, the highest priority.

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