Biosimilars & Complex Generics

Working Group

Biosimilars and Complex Generics

Working Group – 2022

OBJECTIVE:

Identify common ground among health care stakeholders to provide appropriate access to safe and effective biosimilar treatments.

SCOPE:

Develop educational materials on:

The role of biosimilars.
The importance of doctor and patient decision-making on prescribing a biologic and a biosimilar.
The harm caused by “non-medical switching,” or changing between biosimilars and non-biosimilars due to insurance requirements.

BACKGROUND:

At present, biosimilar use is relatively limited the United State – at least in part because biosimilars are not well understood by many healthcare professionals or patients. Healthcare stakeholders need to find common ground on ways to provide access to safe and effective treatments, while also reducing the out-of-pocket costs to patients.

Generics and biosimilars can play a comparable role in the healthcare marketplace, as explained by the FDA: “Biosimilars and generic drugs are versions of brand name drugs and may offer more affordable treatment options to patients. Biosimilars and generics are each approved through different abbreviated pathways that avoid duplicating costly clinical trials.”

However, biosimilars are not equivalent to generic small-molecule drugs, and are much more challenging to develop successfully. Using living cells, a biosimilar developer must create its own unique process to produce an identical outcome to an existing treatment.

Biosimilars are still subject to rigorous testing and evaluation, and any FDA-approved biosimilar should be considered safe and effective. For newly diagnosed patients, a biosimilar is likely an appropriate option. Patients who have been benefiting from the original biologic, however, should not be forced to switch from a biologic to a biosimilar simply because insurance doesn’t want to pay. Deciding whether a biologic or a biosimilar is the appropriate treatment should be left to doctors and patients.