Some of the news reports that followed FDA's recent approval of the blood-thinner Lovenox suggested that it was the Agency's first approval of a biosimilar, or follow-on biologic. (Here's one example.) In a recent interview with Ed Silverman of Pharmalot, Jonathan Pan of Scientia Advisors disputes that Lovenox is a true biosimilar (as vague as that definition may be). Says Pan, "Lovenox is not a biologic like a protein or antibody. It's much simpler but still relatively complex. . . . Momenta and Sandoz somehow convinced the FDA that their product is equivalent in safety and efficacy to the original product without the need to fully characterize the structure and sugar changes in the active molecule." (Read Silverman's full interview with Pan here.)
As Momenta and Sandoz were not able to prove biological equivalence for the drug, FDA, by proxy, relied upon data from a robust clinical trial that proved the drug effected patient responses similarly to the originating drug. In effect, Pan says, this opens the door for other companies to get follow-on biologic products approved via an undetermined extent of clinical trials, not by proving equivalence.
"Using this particular route of approval creates a precedent for building out infrastructure for creating a follow-on or biosimlar approval process as mandated by health care reform," says Pan. "So if you’re a big pharma, you need to pay attention to that, of course." Teva and Amphastar are also "attacking from the same point" in seeking approvals for generic versions of bio products, he says.