Gottlieb's biosimilar bark. But what about the bite?
The FDA commissioner gave a tough speech on biosimilars yesterday at the Brookings Institution while unveiling an 11-point Biosimilars Action Plan.
Gottlieb decried PBMs (Trump administration health officials never seem to miss a chance to take a whack at PBMs) and "rebating schemes" in his prepared remarks. He criticized "patent thickets" that keep biosimilars off the market. And he gave the audience a bit of history lesson on pricing and reimbursement, saying it was designed when payers like Medicare were price takers that weren't in a position to negotiate prices because there was no competition among biologics.
Gottlieb also told the Brookings audience that FDA would be teaming up with the FTC to challenge "gaming tactics" and anticompetitive behavior.
Stay tuned, he said. And we and many others will be.
The action plan itself isn't a hugely revolutionary document. Might the bark here be more than the bite? The 11 points include moderate, sensible steps like standardizing review templates, enhancing the Purple Book, and giving developers additional guidance on interchangeability.
Still, almost anything is going to be better than the current situation. The FDA has approved a paltry number of biosimilars--just 11, Gottlieb said in his speech--and only three are on the market.