NC introduces biosimilar substitution bill as MA looks to amend its law

Like a number of other bills introduced​ in recent months, the North Carolina one will require pharmacists to notify prescribers of the product name and manufacturer of the biosimilar biologic, though North Carolina legislators don’t put a time limit on when the notification should be made, saying it should be a “reasonable time following the dispensing of a biological​.”

The North Carolina bill also requires that the biosimilar must be declared interchangeable by the US FDA. The agency last week approved the first biosimilar for use​ in the US and it was not declared interchangeable. 

In addition, the legislation adds price to the equation, noting that pharmacists should “not select an equivalent drug ​or interchangeable biological ​product unless its price to the purchaser is less than the price of the prescribed drug product​.”

The state Board of Pharmacy also will have to maintain a link on its website to the current list of biosimilars determined by the FDA to be interchangeable with their reference product.

Massachusetts​

Massachusetts, meanwhile, seems to be backtracking a little bit on the need for interchangeability as a recent proposal seeks to switch the words “biosimilar and interchangeable with​” and replace them with the words “therapeutically equivalent to​.”

Massachusetts House Rep. Mark Cusack did not respond to a request for comment on why the law was being altered.

Otherwise, the enacted law​, which was signed by the Governor last June, remains the same and provides that a pharmacist may substitute an interchangeable biosimilar for its reference product unless “the prescriber instructs otherwise in writing​.” Prescribers must be notified in writing within a “reasonable time​” if a switch is made.

The law also stipulates that pharmacists must notify the patient or patient's authorized representative of the substitution. Pharmacist, prescriber and administering practitioner must retain a record of substitutions for at least one year. 

Colorado ​

The proposed changes to the Massachusetts law comes as Colorado’s legislature approved​ its own substitution bill this week.

The bill contains the same notification and interchangeability requirements as the other legislation.

The Biotechnology Industry Organization (BIO) supported the passage of the bill and is urging Gov. John Hickenlooper (D) to sign the bill into law.