WASHINGTON — New Jersey Gov. Chris Christie has approved legislation to create a pathway for the substitution of interchangeable biologic drugs, drawing praise from the Biotechnology Industry Organization (BIO) and BioNJ, a state biotechnology organization.
Christie signed Assembly Bill 2477 into law on Monday, following unanimous passage in the New Jersey Senate and Assembly earlier this year. The legislation sets requirements for pharmacists to dispense biological products.
BIO said Tuesday that the policies outlined in the bill align with its principles on biologic substitution.
“Assembly Bill 2477 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record,” Jim Greenwood, president and chief executive officer of BIO, said in a statement. “By signing this bill into law, Gov. Christie has added New Jersey to a growing list of states that allow retail pharmacies to substitute interchangeable biologic medicines.”
BIO noted that although the Food and Drug Administration oversees the approval of biologic medicines and interchangeability, policies on whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and physicians are covered by state law. Assembly Bill 2477 seeks to preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies, the organization said.
“New Jersey is a leader in biotech innovation, and now Gov. Christie has positioned our state as a leader in adopting policies that will allow patients access to safe and effective therapies as interchangeable biologics are approved by the FDA,” stated Debbie Hart, president and CEO of BioNJ. “Furthermore, these policies will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
The FDA continues to develop a pathway for the development and approval of safe, effective interchangeable biologics, or biosimilars. However, BIO added, there’s still a key role for states to play in ensuring communication of substitution occurs and doctors remain engaged in the process.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” Greenwood explained. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same.”