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Biosimilars: Next Steps for the US Market

This spring, the FDA released the final guidance to drug makers for the approval process for interchangeable biosimilars. This marks an important moment in the process of lowering prices of breakthrough biologic drugs and improving patients’ access to them. It also allows for an opportunity to review the biosimilars marketplace and next steps.

First, a brief review of where we are in the US: As a practicing rheumatologist, I can prescribe only 1 kind of biosimilar to my patients: infliximab. In my experience of using biosimilar infliximab in patients who agree to switch from the bio-originator (Remicade) and those who start it from scratch (so called “biologic naïve” patients), the biosimilar has been therapeutically equivalent, which is to say equally safe and effective as expected with the bio-originator. This is not surprising to me or to my patients, who have heard my counsel about the rigorous FDA approval process and about published data like the 2017 NOR-SWITCH study.

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Barbara Arnago