Bill Creates Pathway for Making Biological Drug Alternatives More Available

On May 8, 2015

Proposed legislation that will allow greater patient access to more affordable FDA-approved biologic medicines was passed unanimously by the New Jersey Assembly Health and Human Services Committee on May 7. The bill, A2477, also includes provisions for physician notification when a biosimilar bill is substituted for a biologic drug.

“Biological medicines are vital to the treatment of conditions such as cancer, diabetes, infectious diseases and a variety of immune disorders,” said BioNJ President and CEO Debbie Hart. “BioNJ’s rallying cry is “Because Patients Can’t Wait,” and the release of A2477 from committee will move us one step closer to ensuring that Patients have access to medications and cures while guaranteeing transparency in the prescription process and protecting Patient safety as well as preserving the doctor-patient relationship.”

“We would like to thank Assemblywoman Pamela Lampitt, Assemblyman Herb Conaway, Jr., M.D., Assemblyman Daniel Benson, Assemblyman Angel Fuentes, Assemblywoman Shavonda Sumter and Assemblywoman Nancy Pinkin for sponsoring the bill and for their continued support in finding cures for Patients,” added Hart. “We also applaud the entire membership of the Assembly Health and Human Services Committee for their careful consideration of this bill.”

Hart acknowledged the support of the Biotechnology Industry Organization (BIO) for the proposed legislation. “This is a prime example of the life sciences community’s commitment to ensuring that innovative medical research into all diseases is preserved and fostered, and that Patients receive the medications they need and deserve,” she said.

The proposed legislation allows pharmacists to substitute biosimilar products provided the conditions set forth in the bill are met. New Jersey already allows chemically-synthesized generic drugs to be substituted for brand-name prescriptions because the active ingredients in the generic version are identical to their brand-name counterparts. However, biological medicines are manufactured through biotechnology using living organisms and are much more complex than traditional, chemically-synthesized drugs. 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.

The bill now awaits consideration by the full Assembly.

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