Posted by Michael Wonder on 27 May 2018
Congress, FDA need to change biosimilar rules to lower drug prices
26 May 2018 - Just days after President Donald Trump unveiled his vague and widely panned plan to curb pharmaceutical prices, the FDA quietly approved a biosimilar to compete with a drug that has cost taxpayers at least $50 billion over the past quarter century.
Alas, this follow-on biologic will arrive long after use of the original drug, which prevents anaemia in cancer and dialysis patients, has faded. A newer, still-patented version of the same protein, whose only improvement is the need for less frequent dosing, has already superseded most uses of the original product.
In carrying out the president's wishes, FDA Commissioner Dr. Scott Gottlieb vowed to crack down on the "shenanigans" that impede generics and biosimilars from coming to market. If he wants a primer on those shenanigans, he need look no further than the sordid saga behind Epogen/Procrit (they're the same drug, epoetin alfa, and are marketed by Amgen and Johnson & Johnson for dialysis and oncology, respectively) and the newly approved biosimilar Retacrit, which is manufactured by Pfizer.
