Biologics and biosimilars

The issue

Biologics are medications produced from living cells that have proved remarkable in treating painful conditions like rheumatoid arthritis, ulcerative colitis, psoriasis, and even some cancers. Biosimilars are similar, cheaper versions of biologics used to treat many of the same conditions. But these treatments are complex substances created from living organisms and are sensitive to minor changes in the manufacturing process. These changes have the potential to make a biosimilar less effective or cause more side effects compared with the original biologic.

The problem

Biosimilars are copies of biologic medications and not generics. While biosimilar attributes are expected to be extremely alike to the reference product, there are minor differences because it is virtually impossible to copy exactly when biologic medicines are extremely complex due to being produced from living cells. Minor differences in these medicines and the way they are administered, could affect safety and effectiveness. Extensive studies into switching from a biologic to a biosimilar, and/or multiple switching between the two, and how it may affect patient safety have not been conducted.

Our position

We support legislation with patient protection provisions and pharmacy-physician communications. Safeguards surrounding interchangeability is necessary at the state and federal level. While U.S. Pain Foundation advocates in enhancing patient access to new and potentially less costly medications, proposed legislation must include transparency protocol; communication between pharmacy and prescriber within days of providing the treatment to the patient, including the specific product and dosages; and make certain that the patient’s health care team is aware of any changes being made to the individual’s treatment plan. Read our full position statement here.