The ACR leadership has done a tremendous job ensuring that biosimilars will work for clinicians and their patients, said Mr. Eich.
“The interest of society is having patients and physicians tell the industry, regulators, others: Here is how biosimilars can actually improve patient care, so patients can benefit and the practice of healthcare is improved,” he said.
Rheumatologists have been at the forefront in the use of targeted biologics and have deep experience to apply to ensure the safety and efficacy of biosimilars for their patients, said Dr. Daikh.
“It’s important that rheumatologists engage in this issue as biosimilars are being developed and as fundamental regulations regarding their production, testing and labeling are being promulgated,” he said.
Susan Bernstein is a freelance medical journalist based in Atlanta.
Terms to Know
Biosimilar: Biological therapy proved to be highly similar to an FDA-approved biological product, known as a reference product. Has no clinical, meaningful differences from the original drug in safety and effectiveness. Minor differences in clinically inactive components are acceptable.
BPCI: Biologics Price Competition and Innovation Act. Passed in 2009 as part of the Patient Protection and Affordable Care Act, created an abbreviated approval pathway for biologic drugs proved to be either highly similar to or interchangeable with an approved biologic product.
Core name: Non-branded name of originator, reference biologic. All products related to this originator will have the same core name, but may have a different, identifying suffix.
Interchangeable: Biological therapy that’s biosimilar to an FDA-approved reference product, but also meets additional standards and may be substituted for the reference product by a pharmacist without the prescriber’s intervention.
Proper name: Non-branded name of biologic drug that reflects its chemical structure or pharmacologic properties.
Proprietary name: Trademarked, brand name of a drug registered for private use by its manufacturer.
Purple Book: Online reference created by the FDA to list biosimilars and interchangeables under their reference products. Similar to existing Orange Book.
Reference product: Original, approved biologic therapy with which a biosimilar or interchangeable product may be substituted. No previously licensed biological product is related to this originator.
Suffix: Four-letter addition to the end of the core name of the biosimilar or interchangeable. The FDA proposes that suffixes be unique, non-promotional and not too similar to those of other products. These suffixes are designed to reduce inadvertent substitution, but it’s not yet confirmed whether an interchangeable will or will not have a unique suffix or will have the same proper name as the reference product.
