Patients Weigh In on Biosimilars

Bret S. Stetka, MD


February 22, 2016

Roles and Regulations

Medscape: During the FDA meeting, you commented: "A biosimilar may be essentially equivalent to a scientist but not to the biologic patient whose life has been transformed." What exactly did you mean by this?

Mr Ginsberg: Scientists are evaluating the similarity using data and statistics. There may be a minimal or inconsequential difference between a reference biologic and its biosimilar. However, to a patient who has tried and failed to respond to multiple biologics and has finally identified one that works properly, even the most minuscule difference between that medicine and its biosimilar could cause the biosimilar to fail. We also need to respect the fact that the patient has most likely spent years finding a biologic that works and so will be hesitant to try something new when the current biologic is working.

Medscape: With biosimilars slated to play an increasing role in the management of rheumatologic conditions, what safeguards and regulations do you feel should be implemented around their approvals and use?

Mr Ginsberg: We'd like to see very strict and aggressive postmarket surveillance, or pharmacovigilance, mandated by the FDA upon biosimilar approval. Patient-powered research networks such as CreakyJoints' "ArthritisPower" (funded by the Patient-Centered Outcomes Research Institute and a part of PCORnet) are well suited to provide real-time, validated insights with patient-reported outcomes, efficacy, and adverse event reports, directly from patients taking these and other medicines.

Medscape: Do you have any final thoughts on the role that biosimilars will play in patient care?

Mr Ginsberg: We are optimistic that biosimilars will live up to their promise of being safe, effective, and more affordable. Patients are hopeful that those cost savings will passed on to them in the form of reduced out-of-pocket expenses (co-pays, deductibles, premiums)—and if those cost savings are not realized by patients as well as the payers, then biosimilars are not relevant to patients.


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