By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLCMiddletown, NJ
The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”
The guidance is the FDA’s official response to the “Biologics Price Competition and Innovation Act of 2009” (BPCIA). The BPCIA allows pharmaceutical companies to make near duplicates of existing, already approved biotechnology products or, as they are commonly called, biosimilars. The idea: generic-type competition will be generated for biotechnology products and drive down prices. The guideline states that the new biological product must be “highly similar to the reference product notwithstanding minor differences in clinically inactive components.” In order to determine biosimilarity, the FDA can ask for physical and chemical characterization of the new biologic as well as animal and clinical data.
The requirement to prove a new product is “highly similar” to an existing product is about as vague as the FDA ever gets. I would say—and you may disagree (which would still prove my point)—that below, the snake on the left is highly similar to snake on the right. The problem here is that the snake on the left is one of the most venomous of all snakes, the coral snake, and the one on the right is the innocuous king snake.
There is a safety issue with both the snakes and the biosimilars. Cozying up to the coral snake because it is highly similar to the king snake would be a mistake. I am positive the FDA is aware of the potential safety issues with biosimilars and equally positive the FDA will be very, very hesitant to approve any biosimilar without clinical testing. I doubt such approvals will ever take place . . . (to be continued)
*“Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”