California Governor Brown Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

Washington, D.C. (October 8, 2015) – The Biotechnology Industry Organization (BIO) commends California Governor Jerry Brown for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.

Governor Brown signed Senate Bill 671 into law this week, following recent passage in both the California Senate and Assembly.

The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO support this important legislation and is grateful to Governor Brown for his leadership on this issue.

“Senate Bill 671 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,” said Jim Greenwood, BIO’s President and Chief Executive Officer.  "By signing this bill into law, Governor Brown has added California to a growing list of states that allow retail pharmacies to substitute interchangeable biologic medicines."

While the U.S.  Food and Drug Administration (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 671 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies.  BIO will continue to advocate for full communication in the substitution process, as patients and their physicians should have the complete record of what biologic medicine the patient receives from the pharmacy.

“California is a world leader in biotech innovation, and now Governor Brown has positioned his state as a leader in adopting policies that will allow patients access to safe and effective therapies when the first interchangeable biologics are approved by the FDA,” said Greenwood.  “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.”

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.  In fact the FDA has indicated they expect to see applications for interchangeable biosimilar product approvals this year.  However, there is still 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.  Even slight changes to a biologic drug can change its properties entirely,” said Greenwood.  “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.  Those suggesting interchangeable biologics and generics are the same are 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 allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided. 

As the California Legislature continues to address issues related to biologic medicines, BIO encourages policy makers to continue to put patients first. 

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