Tennessee Governor Signs Bill Enabling Biosimilar Substitution

Tennessee has joined a growing list of 11 states to pass legislation enabling pharmacists to substitute a biosimilar for a branded biological product, in a move applauded by industry.

Under the law, doctors must allow for substitution with an interchangeable biological product unless the substitute is ineffective, causes an adverse reaction in the patient or there is another clinically based need. Pharmacists must inform patients of the substitution by noting it on the label, and provide the prescriber the product’s name and manufacturer within a reasonable amount of time.

While the FDA oversees approval of biologic medicines and designation of interchangeability, state law covers policies governing whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and doctors.

Tennessee’s House and Senate unanimously passed Senate Bill 984 last month, and Gov. Bill Haslam signed the legislation on May 4. The 10 other states that have enacted biosimilar substitution laws are Massachusetts, Delaware, Florida, North Dakota, Utah, Indiana, Oregon, Virginia, Colorado and Georgia.

Legislation has also passed in Washington state, but had not been signed by the governor as of press time Friday. Biosimilar substitution bills are progressing in nine other states.

Read the Tennessee law here: www.fdanews.com/05-15-Tennessee-Bill.pdf. — Jonathon Shacat