Biosimilar Drugs Gaining Traction with the FDA

Ethan Mobley, MJLST Staff Member

Recently, an FDA-commissioned panel recommended the Administration approve a cancer fighting drug developed by Novartis called EP2006. The recommendation is significant because if the FDA follows the panel’s advice and approves the drug, it will be the first time the FDA has approved a “biosimilar” drug under the Biologics Price Competition and Innovation Act (BPCI Act). A biosimilar drug is a drug that is “interchangeable” with or “highly-similar” to a biological drug already licensed by the FDA. In the words of the FDA, “[a] biological product may be demonstrated to be ‘biosimilar’ if data show that the product is ‘highly similar’ to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency.” Interestingly, a biosimilar drug is not considered to be a generic version of its already-approved counterpart– only bioequivalent drugs could be generics. Nonetheless, biosimilar drugs are still desirable for consumers because they are subject to an expedited approval process compared to their already-approved counterpart. Such drugs would be readily substitutable by a pharmacist without requiring the prescriber’s permission.

In this case, the panel advised the FDA that EP2006 is biosimilar to Amgen’s medication, Nuopogen (filgrastim), which is used to boost white-blood cell production in the body. Unfortunately, Neupogen is predictably expensive. But, introduction of EP2006 into the market would make cancer-fighting medication more price-accessible for many patients. Such a decrease in price would necessarily follow from increased competition for a white blood cell-producing drug and the reduced development costs of EP2006 attributable to the expedited approval process under the BPCI Act. Ideally, a groundbreaking approval of EP2006 under the BPCI Act would also pave the way for other price-accessible medication meant to treat all sorts of ailments.