Massachusetts Enacts Biosimilar Substitution Law 07/22/2014Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
Tags: biological products, biosimilar, FDA, pharmacist, vaccines, viruses
By: Stanley Chalvire
Massachusetts recently enacted Chapter 143 of the Acts of 2014, entitled “An Act relative to the substitution of interchangeable biosimilars,” authorizing pharmacists to fill prescriptions that are written for brand name biological products with the corresponding and generally less expensive biosimilar product. A biosimilar is a biological medicine that the U.S. Food and Drug Administration (FDA) has determined is highly similar to an FDA-approved biological product, notwithstanding minor differences in inactive components, for which there are no clinically meaningful differences between such biosimilar product and the reference biological product in terms of safety, purity and potency.
The Act defines “biological product” to include, for example, viruses, vaccines, blood components or derivatives and certain proteins that are applicable to the prevention, treatment or cure of a disease or condition of human beings. An “interchangeable prescription biological product” is defined as a biosimilar that has been determined by the FDA to be substitutable with the prescribed reference biological product.
The Act generally tracks existing Massachusetts laws governing the substitution of generic drugs for prescribed brand name drugs. In particular, the Act provides that:
- A pharmacist filling a prescription for a biological product prescribed by its trade or brand name may substitute an interchangeable biological product;
- The prescriber can instruct against substitution of an interchangeable biological product on a patient-specific basis;
- The dispensing pharmacist or the pharmacist’s designee must notify the prescribing practitioner and the patient of the substitution;
- The dispensing pharmacist or the pharmacist’s designee, the prescribing provider and administering practitioner shall retain a record of each substitution, for not less than 1 year from the date of the last entry in the profile record; and
- In the event of noncompliance by a pharmacist or a practitioner, the purchaser or patient may inform the director of consumer affairs and business regulation of such noncompliance.
The FDA has yet to approve a biosimilar product, much less an interchangeable biosimilar product which pharmacists in Massachusetts would be permitted to substitute under the Act. Massachusetts now joins Florida, North Dakota, Oregon, Utah, Virginia and Indiana on the forefront of states enacting laws governing the substitution of biosimilars.
For more information on the Act or biosimilars, please contact Stan Chalvire.