Legislation sponsored by Assembly Democrats Pamela Lampitt, Herb Conaway, Jr., M.D., Daniel Benson, Shavonda Sumter and Nancy Pinkin to make it easier for consumers to obtain more cost-effective, “generic” versions of biological medicines used to treat conditions such as rheumatoid arthritis, anemia, psoriasis and various forms of cancer has been signed into law.
“The FDA has created a safe pathway to make alternative biological medicines more readily available on the market,” said Lampitt (D-Camden/Burlington). “If there is a more cost-effective option to treat and cure various illnesses, then by all means we should be helping patients pursue it.”
“Substitution of these biologically similar products for their name-brand counterparts at the pharmacy level is expected to reduce cost by increasing competition,” said Conaway (D-Burlington). “Ultimately, this will allow more patients to access treatments.”
While New Jersey has allowed chemically-synthesized generic drugs to be substituted for brand-name prescriptions for quite some time because the active ingredients are identical to their brand-name counterparts, biological medicines, on the other hand, are manufactured through biotechnology using living organisms and are much more complex than traditional, chemically-synthesized drugs.
However, changes created under the federal “Patient Protection and Affordable Care Act” made it easier for biosimilar biological products to gain licensure from the federal Food and Drug Administration (FDA). Over the past eighteen months, approximately 23 states have considered legislation establishing state standards for the substitution of biosimilar prescription products and as of December 31, 2014, eight states had enacted statutes.
The new law (A-2477) adds New Jersey to that list, allowing for the substitution of biosimilar products by pharmacists, provided the conditions set forth in the law are met.
“For lower income families or seniors on a fixed-income who might not be able to afford the name-brand version of these innovative medicines, this can be a game changer,” said Benson (D-Mercer/Middlesex). “This law will provide more people with greater access to life-altering treatments.”
“Certain biological drugs on the market today can drastically improve a person’s outcome and should be made more readily accessible,” said Sumter (D-Bergen/Passaic). “Simply put, biosimilar medicines cost less and can save lives.”
Specifically, the law directs the State Board of Pharmacy to maintain a link on the board’s website to the current list of all biological products determined by the FDA to be interchangeable. A pharmacist is allowed to substitute such a product for a prescribed biological product if the prescriber has not indicated that there be no substitution.
A pharmacist, who dispenses a biological product must communicate the name of the product and the manufacturer to the prescriber within five business days after dispensing unless there is no biological product that has been determined by the FDA to be either interchangeable with the product described; or a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
“For people with many rare conditions, biological medicines can dramatically enhance their quality of life, but they come at a significant price,” said Pinkin (D-Middlesex). “This law will help change all that by providing a more cost-effective alternative.”
Under the law, a pharmacist who substitutes a biological product must record, on the prescription label and record of dispensing, the product name and manufacturer of the biological product dispensed, followed by the words: “Substituted for” and the name of the biological product for which the prescription was written. The same recordkeeping requirements as apply to the dispensing of drugs will apply to the dispensing of biological products.
The law provides immunity from liability for a pharmacist who makes such substitutions in compliance with the law to the same extent that immunity would be provided for dispensing the prescribed biological reference product.