Biosimilar drugs are nearly identical to already-approved biological drugs, but there are slight chemical differences. Biosimilars are primarily different because their active drug substance originated from a living organism, unlike biological drugs.
“Our commission has been working diligently since the end of last session to address different health care issues,” said Rep. Zent. “I was pleased that we were able to take proactive steps regarding the dispensing of biosimilar drugs. The forward thinking of the committee’s recommendation should benefit Hoosier families in the coming years.”
The commission’s recommendation regarding biosimilars says that pharmacists may substitute a biosimilar drug for a prescribed biological drug if the following conditions are met:
1. the biosimilar drug has been determined by the FDA to be interchangeable with the prescribed biological drug;
2. the doctor’s prescription includes the words “may substitute”;
3. the pharmacist has informed the customer of the drug substitution;
4. the pharmacist notifies the prescribing doctor within five calendar days of the substitution; and
5. the pharmacy and the prescribing doctor retain a written or electronic record of the interchangeable biosimilar substitution for at least five years.
“In short, if a pharmacist dispenses a biosimilar drug in place of a prescribed biological drug, he or she must notify both the prescribing doctor and the patient within five days,” said Rep. Zent. “As a healthcare provider, I understand the trust involved with doctor-patient relationships. Our committee’s recommendation helps protect this sacred relationship by ensuring that both the doctor and patient know exactly what medication is being taken.”
As part of the Legislature’s interim study process, the Health Finance Commission met five times between June and October of this year. During those meetings, the commission heard testimony from experts on a wide range of healthcare issues expected to be considered during the next session.
Rep. Zent (R-Angola) represents large portions of LaGrange and Steuben counties.