Biosimilars legislation approved in New Jersey
Legislation sponsored by Assembly Democrats of the New Jersey General Assembly (Pamela Lampitt, Daniel Benson, Shavonda Sumter, Nancy Pinkin, and Herb Conaway Jr., M.D.) 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 are manufactured through biotechnology using living organisms and are much more complex than traditional, chemically synthesized drugs.
Changes created under the federal “Patient Protection and Affordable Care Act,” however, made it easier for biosimilar biological products to gain licensure from the FDA. Over the past 18 months, about 23 states have considered legislation, establishing state standards for the substitution of biosimilar prescription products and as of Dec. 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.
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.