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.

For many people receiving biosimilars—and their fellow beneficiaries of public and commercial insurance—total drug costs are falling. Remicade costs about 30% less than it used to (after decades of price increases) and biosimilar infliximabs cost more than 15% less than Remicade. But biosimilar uptake and price reductions have been modest, and several changes could fix that.

The first thing that could improve the biologics marketplace is competition. Only 2 biosimilars are available for rheumatologic diseases, but 6 other biosimilars (3 adalimumabs, 2 etanercepts, and 1 infliximab) are FDA-approved but not marketed due to legal disputes and drug-maker decisions. When they do become available, prices should drop again.

Furthermore, now that the FDA has given drug makers a pathway to seek an interchangeability designation, it is hoped that clinical studies will produce rigorous switching data and possibly increase the number of biosimilars. The data will arise from studies in which patients switch 3 times, alternating from the bio-originator to the biosimilar, back to the bio-originator, and finally to the biosimilar.

Data from switching studies will bolster another important facet of the biosimilars marketplace: patient and prescriber confidence. In a marketplace in which patients move from one formulary to another and from one year to the next in their journey with chronic illnesses, it will be helpful to know that interchangeable biosimilars offer equal safety and efficacy after multiple switches.

Finally, in addition to improved competition and confidence in biosimilars, incentives could be improved. Patients should share in the savings of biosimilars by being exempt from copays. Reimbursement systems should also account for the extra work and time required of prescribers to counsel their patients about biosimilars. And, as has been pointed out previously, the rebates in the US drug distribution system—which can incentivize higher prices—must be reformed so that pharmacy benefit managers and other organizations support prescribers and patients who choose biosimilars instead of blocking them.