MichBio Helps Push Biosimilars Substitution Legislation Through Michigan House
Wednesday, November 18, 2015
Posted by: Kate Oesterle
Legislation that would regulate the sale and distribution of biosimilar drugs has cleared the Michigan House by a 101-5 vote. This came on the heels of a prolonged debate at the House Health Policy Committee that considered two competing bills.
MichBio in concert with a coalition of industry, patient and physiican stakeholders worked diligently to ensure passage of HB 4812 in the Michigan House. The bill was sponsored by Rep. John Bizon, MD (R-Battle Creek). It addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the prescribed biological product. Eighteen states have passed biosimilar substitution laws and several states have bills pending in their current legislative sessions.
Specifically, HB 4812 permits a pharmacist to substitute a biosimilar for the prescribed reference product if:
· The FDA has approved the biosimilar drug as interchangeable with its reference product;
· The prescriber has not conveyed a limit on substitution to the pharmacist by one of the methods set out in the statute;
· The substituted product will cost the purchaser less than the prescribed product; and
· The pharmacist communicates the substitution to the purchaser in writing and orally, labelling both the container and the prescription accordingly.
· The pharmacist notifies the prescriber of the substitution within five days of dispensation.
Communication to the physician by a pharmacist was the stickiest point during Committee deliberations. The Michigan Pharmacists Association, Michigan Association of Health Plans, Michigan Retailers Association, along with a few related national groups, opposed HB 4812. Instead, they supported a competing bill that held no requirement for pharmacists to notify a prescriber of an interchangeable biosimilar substitution. HB 4812 will assure that in the event of unexpected outcomes, patients, doctors and pharmacists all have up-to-date information on the patient’s mode of treatment.
The legislation is supported by numerous state and national patient/disease advocacy groups, physician societies, biopharmaceutical industry organizations and pharmaceutical companies. MichBio has been at the forefront as the biosimilar substitution legislation has worked its way through the legislative process.
The legislation now heads for the state Senate for their consideration.