The bill, which was adopted by the New Jersey legislature in May, gives pharmacists new powers without stripping physicians of control and oversight over the prescribing process. At the heart of the bill is a short statement with far-reaching consequences for the future of biosimilars in the state.
“A pharmacist may substitute a biological product for a prescribed biological product,” the law states. The statement clears pharmacists to decide whether to give patients a biosimilar or innovator version of a product and in doing so will potentially facilitate the update of copycat therapies.
However, the law also contains stipulations to prevent the balance of power between pharmacists and physicians from tipping too far in favour of the former. Pharmacists can substitute biologics “provided that the following conditions are met,” the law states.
The conditions touch on an array of issues relating to biosimilars. Top of the list of restrictions is a sentence preventing pharmacists from giving out a biosimilar whenever the prescriber prohibits such substitution in their script.
Pharmacists are further limited by the United States Food and Drug Administration (FDA). The New Jersey law only allows substitution of biosimilar products FDA has deemed to be interchangeable and therapeutically equivalent to the reference biologic.
When pharmacists are able to substitute a biosimilar, they must then complete certain actions. Within five business days, the pharmacist must tell the prescriber the name of the manufacturer and brand of the product they gave to the patient.
The law allows for the pharmacist to communicate this information by updating an interoperable medical records system to which the prescriber has access. Other electronic forms of communication or fax are also acceptable.
Importantly for pharmacists, substituting a biosimilar for a reference product carries no additional liability.
The signing of the bill by Christie, a participant in the race to be the 2016 Republican presidential candidate, has the backing of a broad cross section of the biopharmaceutical industry, in part because of the restrictions and requirements it places upon pharmacists.
“Assembly Bill 2477 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies," Jim Greenwood, president and CEO of BIO, said.
"This bill includes communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record."