FDA Releases Biosimilar Educational Materials for Patients

Today, the FDA released a new suite of resources to educate patients about biosimilars.

The new materials, “Biosimilars Basics for Patients,” explain that biosimilars are safe and effective medications that “are FDA-approved biologic medications that are compared to another medication—the original biologic.” The FDA describes biosimilars are being made “from natural sources” and developed “using advanced science.”

The resources explain that biosimilars can be expected to have the same benefits and risks, and that they may provide more treatment options, increase competition in the marketplace, and allow for lower costs.

The FDA also provides a brief overview of the ways in which it ensures that biosimilars are safe and effective, including reviewing data, monitoring drugs post-launch, and reviewing patient safety reports.

A frequently-asked-question (FAQ) section of the guide addresses questions such as how patients can tell whether they are receiving a biosimilar (the FDA suggests asking a doctor or pharmacist), whether it is safe to switch to a biosimilar (biosimilars can generally be used whether or not a patient has been first treated with a reference, says the guide), and whether individual patients can expect to see cost savings from biosimilars (health insurance plan providers are best situated to provide this information, according to the FAQ).

The FDA’s materials also include a “Biosimilar Basics” infographic and a one-page explanation of biosimilars that highlights the fact that “prescribers and patients should have no concerns about using these medications instead of reference products.”

The resources deliver on the Biosimilar Action Plan’s commitment to develop effective communications to improve upon the understanding of biosimilars among patients and other stakeholders. In the plan, the FDA committed to developing a “one-pager” for patients and to pursue video-format communications that can be disseminated on social media for patients and other key audiences.