How to Label Biosimilars: Groups Disagree

The drug industry, the AARP and pharmacists disagree on what information should be included in biosimilar labeling.

In comments on a draft guidance released by the Food and Drug Administration in March, the Pharmaceutical Research and Manufacturers of America (PhRMA) said that labels should say the product is a biosimilar. The drug industry group also said labeling should describe the relevant data from studies that support a finding of biosimilarity with the reference, or brand, product and should state whether the product meets a higher standard of interchangeability with the reference product.

Meanwhile, the AARP and the Academy of Managed Care Pharmacy (AMCP) said labels shouldn't include a statement that the product is a biosimilar because this could create confusion and discourage biosimilar adoption.

Comments on the draft guidance were due June 3, but the FDA extended the comment period until Aug. 2 (Docket No. FDA-2016-D-0643).

A biosimilar is a biological product that is approved by the FDA based on a showing that it is highly similar to an already approved biological product, known as a reference product (RP) or brand biologic. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness. The Affordable Care Act created an abbreviated pathway for the FDA to approve biosimilars.

So far, the FDA has approved two biosimilars: Zarxio (filgrastim-sndz), Sandoz's biosimilar of Amgen's cancer treatment Neupogen and Inflectra (infliximab-dyyb), Pfizer's and Celltrion's biosimilar of Johnson & Johnson's arthritis treatment Remicade.

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