Biotech innovators score this time by backng a new law in Virginia that dictates rules for allowing interchangeability of biosimlars for the original biologic drug. The legislatins requires tha FDA must have specifically deemed the biosimilar to be interchangeable with the prescribed biologic for the indication in question. Physicians will also have the authority to specify "Do not substitute." FDA, of course, has not even approved ONE biosimilar yet.
"The legislation properly preserves the physician-patient relationship, protects patients, maintains incentives for innovation, and promotes a competitive market for biologic therapies. Furthermore, it is a model for legislation necessary in all 50 states to address vital drug safety measures that accompany this cutting-edge technology," in BIO issued statement.
BIO certainly is reflecting the opinion of its members. This pre-emptive law will make substitution harder. No doubt it will help protect member revenues. It may protect patients (but not their wallets). It won't make any 3rd party payers happy. And it is all too reminiscent of the battles that went on when generics were first introduced. Nobody thinks twice about substitution with generics now.
Posted by Bruce Lehr Mar 22nd 2013.