The Biotechnology Innovation Organization (BIO) and Pennsylvania Bio commend Governor Tom Wolf for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.

Governor Wolf signed Senate Bill 514 this week, following unanimous passage in both the Pennsylvania Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support. BIO and Pennsylvania Bio are grateful to the legislature and Governor Wolf for their leadership on this issue.

“Senate Bill 514 enjoys the support of physicians across Pennsylvania and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes provisions to ensure appropriate communication on all biologic medicines dispensed, in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s president and chief executive officer. "By signing this bill into law, Governor Wolf has added Pennsylvania to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines."

While the FDA oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. Senate Bill 514 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies. BIO supports full communication in the substitution process, as patients and their physicians should know what biologic medicine the patient receives from the pharmacy.

“We’re pleased to see Pennsylvania adopting policies that not only support a growing industry in our state, but more important, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA,” said Pennsylvania Bio President & CEO Christopher Molineaux. “This important bill will provide patients more opportunities to address their medical needs, particularly severely ill patients who rely on complex biological treatments.”

While the FDA has approved biosimilar products for sale in the U.S., the agency continues to develop a pathway for the development and approval of safe and effective interchangeable biologic products. There also remains a major role for states to play in ensuring communication of substitution occurs and physicians remain engaged in the process.

“Interchangeable biologics are not generics,” said Greenwood. “Unlike conventional generic medicines, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same and should be treated the same are just plain wrong.”

Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians about product substitution allows everyone involved the opportunity to discuss past treatment experiences, so that any possible unexpected issues can be better understood and properly addressed.

“On behalf of the life science researchers, manufacturers, healthcare professionals, and patient partners that work together to make life better for patients and their families across Pennsylvania, we thank Governor Wolf for signing this important bill into law and thank Senator Patricia H. Vance for her leadership in sponsoring Senate Bill 514,” said Molineaux. “The hard work of these leaders resulted in unanimous support in both chambers. This is a great example of how we can all work together to do the right thing for the people of Pennsylvania.”