A. Potential patent expirations for biologics allow for introduction of biosimilars. B. Abbreviated but rigorous development programs may provide cost savings without compromising quality. C. Competition may increase access to biologic products for appropriate patients. D. Clinical efficacy is increased with biosimilars compared with the original biologic.

A. They are essentially generic versions of the original product. B. They may be classified as “biobetters” in that they have increased clinical efficacy compared with the original product. C. They may be classified as “biomimics” in that they are copies of already-licensed biological products that have not met the regulatory criteria for biosimilars. D. An exact copy of a biologic cannot be made.

A. There were more adverse cardiac events in the reference product. B. There were similar numbers of adverse cardiac events in the 2 therapies. C. There were more adverse cardiac events in the ABP980 arm. D. Right ventricular ejection fraction was the main parameter that was measured.

A. The biosimilar will be more effective than the reference product. B. The biosimilar will be safer than the reference product. C. Physicians may need to extrapolate data for the biosimilar for certain indications. D. The biosimilar will have a different route of administration than the reference product.