Introduced earlier this year by Assemblywoman Pamela Lampitt, Assembly Bill No. 2477 outlines the guidelines that will govern the prescribing and dispensation of biosimilar products in New Jersey. As required by the Affordable Care Act, every state is required to implement biosimilar guidelines.
As part of its advocacy efforts, BioNJ has teamed up with Discovering Cures New Jersey, which is part of a national coalition involving the Biotechnology Industry Organization (BIO), and other associated groups, to help patients, patient advocates, members of the legislature and their staff and the general public gain an understanding of the medical and regulatory issues involved in the introduction of biosimilars to the marketplace.
BioNJ and Discovering Cures New Jersey held its first briefing this June at a Lunch & Learn in Trenton attended by more than 30 patients, patient advocates and legislative staff members.
Speakers included Debbie Hart, President and CEO of BioNJ, Fritz Bittenbender, Executive Vice President of Public Affairs at BIO and Dr. Carlos Sattler, Vice President of Clinical Development and Medical Affairs at Sandoz, a Novartis Company.
As the legislation moves forward, BioNJ and Discovering Cures will stress that it is essential to have rules in place covering the use of biosimilars that will facilitate patient-physician-pharmacist communication and ensure the creation and safekeeping of accurate medical records.
BioNJ and Discovering Cures are advocating that 1) biological substitution be limited to interchangeable products; 2) physicians retain dispense-as-written authority; 3) patients are aware of the biologic products dispensed; and 4) pharmacy records are maintained.