Drugs

Add Clinical Data to Biosimilar Labeling: Comments

The Alliance for Patient Access says it is concerned that biosimilar labeling may not include relevant clinical trials data submitted by the applicant. Commenting on an FDA draft guidance on labeling for biosimilar products, the alliance says that rather than recognizing the difference between a biosimilar drug and its reference product, the proposed guidance appears to favor an approach more like that used by traditional drugs. “Although the clinical studies on biosimilars are designed to demonstrate biosimilarity to the reference product and not to independently establish the safety and efficacy of the biosimilar,” the group writes, “the data will have value to prescribers as they determine which biosimilars are appropriate for which patients.” The letter says that the draft also overlooks physicians’ and advocates’ concerns on the issue of indication extrapolation, the process by which FDA relies on a drug’s biosimilarity to approve it to treat diseases for which it has not been thoroughly tested.

Janssen says it supports the draft in some respects, especially the recommendation to include a statement of biosimilarity in the label of a biosimilar. “However, we believe that the guidance can be significantly improved by including a statement about the interchangeability status of the biosimilar and including in the biosimilar label the relevant clinical study data that supported the approval of the biosimilar,” it says.

In its comments, the International Foundation for Autoimmune Arthritis also encourages inclusion of clinical information for both the biosimilar and the reference product. “Given the uniqueness of autoimmune/auto-inflammatory diseases,” the letter says, “including a high rate of comorbidities within the patient population, patients, prescribers, and payers will require this safety and efficacy information to make fully informed choices when determining appropriate treatments.”

Pharmaceutical Research and Manufacturers of America (PhRMA) says biosimilar labeling should (1) describe the basis for approval for each indication by identifying the relevant data for the biosimilar that support a finding of biosimilarity and (2) state whether FDA has made a determination of interchangeability with the reference product and include any such FDA finding.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome