Globally, governments have or are developing regulatory pathways to approve follow-on-biologics (FOBs) as alternatives to innovator-developed, biologic, large molecule medicines.
An FOB, also known as a biosimilar, is a biological product for which marketing approval would be granted based on less than a full safety and efficacy package due to the physical/structural similarity of the FOB to an already-approved biologic product as well as reliance on the finding of safety and efficacy of the already-approved product. An FOB is not a generic, (i.e., a product approved as an identical copy of an already approved product based on bioequivalence and without any supporting safety or efficacy data) but is a highly similar version of an already‐approved reference product. The two are not identical.
The regulator’s approval process for FOB products must be scientifically reliable, procedurally transparent, and must respect the reference product’s manufacturer’s proprietary information, intellectual property, and other rights. Lilly supports a regulatory pathway for FOBs that protects patients and innovation.
Absent compelling data, a biosimilar should be reviewed and approved as interchangeable at the prescriber level only after it is safely marketed as a biosimilar product for a reasonable period of time in an adequate number of patients. Achieving the regulatory status of an interchangeable biosimilar should ordinarily be allowed only after it is determined that the switching of the follow‐on biologic product for the innovator product poses no additional safety concerns beyond those already identified with the use of the reference product alone.
While FOBs are an important addition to the treatment options for patients, it is important that the choice of medicine remains in the hands of physicians and patients working together. There should be no mandatory substitution of the FOB for the originator at the pharmacy level as it creates risks for patient safety and could negatively affect patient outcomes. Because FOBs and the originator biologic are not identical, it is important for physicians to have the opportunity to gain experience using either treatment option and prescribe accordingly without a different biologic being dispensed at the pharmacy.