Hillel P. Cohen
As biosimilars enter the United States market, there is a new vocabulary that doctors, patients and patient advocates need to learn as it is important to understand the difference between “biosimilars” and “interchangeable biologics.”
As defined in the law that created the biosimilar pathway in the U.S. — the Biologics Price Competition and Innovation Act of 2009 (BPCIA) — biosimilars are biological drugs that are designed to match the features of the biological reference medicine, and for which evidence is provided that there are no clinically meaningful differences.
Although interchangeable biologics are also described in the BPCIA, these are biosimilars that the FDA has determined meet the additional data requirements for interchangeability. To obtain an interchangeability designation, the manufacturer must conduct an additional clinical switching study to prove that it is possible to switch back and forth multiple times between the biosimilar and reference biological medicine without any loss of efficacy or any additional safety concerns compared with patients treated continuously with only the reference biologic.
There is a new vocabulary that doctors, patients and patient advocates need to learn as biosimilars enter the U.S. market, according to Hillel P. Cohen, PhD.
Once a biosimilar is granted a designation of interchangeable biologic by the FDA — and where permitted by state law — pharmacists can dispense the interchangeable biologic in place of a prescribed reference biological drug without having to first request permission from the prescribing physician or nurse practitioner.
Physicians always have the ability to prescribe whatever drug they deem to be most suitable for their patients; interchangeability only applies when the biologic is dispensed by a pharmacist. Therefore, in nonpharmacy settings where patients may receive a drug, such as a doctor’s office or an outpatient clinic, the designation of interchangeability is not relevant to patient treatment.
The quality of a proposed interchangeable biologic — that is to say, the structure, function and even the impurities — are not changed in any manner before the clinical switching study is conducted. In the case of a manufacturer “tweaking” a biosimilar molecule before conducting an interchangeability switching study, it would be viewed as a new biosimilar that would require a completely new and comprehensive data package. As a result, the quality requirements for biosimilars and interchangeable biologics are identical.
It is important for anyone prescribing or using a biological drug to know that the FDA has a single standard for safety and efficacy for all biological drugs. The FDA will not approve any biological drug — whether it is an original biologic getting approved for the first time, a biosimilar to an already licensed reference product or an interchangeable biologic — unless the agency is convinced that the biological drug is safe and effective for its intended use. As a result, patients and their health care providers can be confident that both biosimilars and interchangeable biologics will be just as safe, and provide the same efficacy benefits, as the biological reference product.
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Hillel P. Cohen, PhD, is co-chair of the education committee of the Biosimilar Forum, a nonprofit organization intended to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care.
Disclosure: Hillel reports employment relationships with Sandoz and owns stock in Novartis.