What Is a Biobetter?

Whereas “biosimilar” is a clearly defined regulatory term, “biobetter” is essentially a marketing term with no universally accepted definition.

Biosimilars are licensed (approved) by the FDA because they are highly similar to an already FDA-approved biological product (the reference product). A biosimilar has no clinically meaningful differences in terms of safety and effectiveness from its reference product; it also must have the same mechanism of action, route of administration, dosage form, and strength as the reference product.

In contrast, a biobetter (or “biosuperior”) can be thought of as an improved version of an existing biological product. For example, a biobetter may have a change in structure that makes it safer or more effective, or a change in formulation that makes it easier to administer or allows fewer courses of treatment. Biobetters are different from the existing product and evaluated as new drugs.

The monoclonal antibody Gazyva (obinutuzumab; Genentech, Inc.) is considered to be a biobetter of Rituxan (rituximab; Biogen Inc. and Genentech, Inc.). Both drugs target the CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes. In several head-to-head comparisons of Gazyva and Rituxan, Gazyva showed superior efficacy.