Legislation that allows for greater patient access to more affordable FDA-approved biologic medicines was approved unanimously by the Senate Health, Human Services and Senior Citizens Committee. The bill now moves to review by the full Senate.
"This legislation, over a year in the making, represents a thoughtful, balanced approach to providing new medicines while protecting patient safety," said Debbie Hart, president and CEO of BioNJ, a network of member investors representing research-based life sciences companies. "BioNJ's rallying cry is 'Because Patients Can't Wait', and the passage of S1705/A2477 moves us one step closer to ensuring patient safety and that they will have access to medications and cures, while guaranteeing transparency in the prescription process and preserving the patient-physician relationship."
The legislation allows biosimilars—biological products that have been approved by the FDA—to be substituted for biological products under certain specific conditions. Biosimilars are similar to previously approved biological products and have the potential to be less costly than the original product.
"With the first alternative biologic medicine already approved by the FDA and more in the approval process, a safe pathway for these drugs to enter the market needs to be in place," said Assemblywoman Pamela Lampitt (D-6), the bill's sponsor in the assembly. "Biosimilar products may offer patients a cost-saving alternative to their current biologic medication. It is not only important that New Jersey residents have access to these less expensive medications, but also that we have regulation in place that will ensure patient safety."
"Like all drugs approved by the FDA, biosimilars must meet standards of safety and efficacy," said Hart. "However, unlike generic drugs that are produced from chemical compounds, biologics come from living organisms and can never be duplicated exactly. It is for this reason 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."
"This legislation helps to ensure that patients will have access to life-saving medicines and treatments, while making sure that there is effective communication between the pharmacist, doctor and Patients, which is key to ensuring patient safety," said committee chairman Senator Joseph Vitale (D-19).