Christie Approves Biosimilars Legislation

On Nov 10, 2015

New Jersey Governor Chris Christie approved biosimilars legislation today, ensuring patient safety as they access this new category of FDA-approved biologic medicines.

“We applaud the Governor for supporting this legislation,” said Debbie Hart, president and CEO of BioNJ. “As a result of the signing of this bill, New Jersey residents will now have access to these life-saving medications while knowing that their safety is protected.”

Biosimilars are the next wave in medicine. Biological products, or biologics, are made from human and animal sources or are synthesized in laboratories from living organisms. Examples of biologic processes include organ and tissue transplants, stem cell therapy, immunization and gene and cell therapies. Because of their unique nature and the unique process required to develop them, it is impossible to produce an exact copy of an innovator biotech medication. Biosimilars are biological products that have been approved by the FDA because they are similar to previously approved biological products.

Just as generic copies of drugs are less expensive than the original products, biosimilars have the potential to save billions of dollars. Some researchers predict that with the approval of this new legislation, healthcare payers could save more than $250 billion over 10 years, depending on which drugs actually come to market. However, because biosimilars can never be exact replicates of a biologic drug, the legislation put in place by Governor Christie guarantees transparency in the prescription process while preserving the patient-physician relationship, ensuring patient safety.

“I commend Governor Christie for signing this critical legislation into law. Thanks to the Governor’s leadership, New Jersey has joined a growing list of states that will allow retail pharmacies to substitute interchangeable biologic medicines when these innovative medical therapies are approved by the FDA,” said Jim Greenwood, BIO’s president and Chief Executive Officer. “This legislation will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
“We acknowledge Assemblywoman Pamela Lampitt (D-6), who championed this legislation throughout the process even testifying in support and we thank her for her leadership on a complex and important issue,” added Hart.

With the first alternative biologic medicine already approved by the FDA and more in the approval process, this new legislation guarantees a safe pathway for these drugs to enter the market.

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