- The Kentucky state Senate last week passed a bill governing when a pharmacist can substitute a biosimilar product for a branded biologic drug. It advanced easily by a vote of 36 to 1, sending it to consideration by the Kentucky House of Representatives.
- Pushed heavily by the pharmaceutical industry, the bill would allow pharmacists to switch a branded biologic for a biosimilar, but only if the biosimilar drug is designated as "interchangeable" by the FDA. Sandoz' cancer drug Zarxio (a copy of Amgen's Neupogen) is currently the only approved biosimilar in the U.S., but it is not designated as interchangeable.
- Additionally, the bill requires pharmacists to notify a patient's doctor within five days if the patient is switched from a branded biologic to a biosimilar.
Since no interchangeable biosimilars are currently available, the bill would have no immediate effect. However, its importance—and the importance of bills similar to this one—will only grow as biosimilars become more common in the U.S.
The pharmaceutical industry lobbied heavily for this bill, increasing spending and lobbyist presence in Frankfort, KY, as noted by the Kentucky Center for Investigative Reporting (KYCIR). The notification requirement could increase the burden of prescribing biosimilars, indirectly favoring continued prescriptions for branded drugs.
The Kentucky Pharmacists Association opposed the bill, telling KYCIR the requirements would increase costs and lead to more brand dispensing. However, only one lawmaker—the Senate majority whip, Jimmy Higdon—agreed with the KPhA's position.
There are other ways in which biosimilars manufacturers are being hamstrung. For example, one of the provisions of the Biologics Price Competition and Innovation Act (BPCIA) forces biosimilar developers to give a branded manufacturer 180-day notice before launching its product.
This issue is at the heart of Sandoz's recent petition to the Supreme Court asking it to overturn a federal appeals court decision which effectively gave brand-name manufactures more time to fight biosimilar competition.