California gives green light to substitution of biologics

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WASHINGTON — California Gov. Jerry Brown has approved legislation to create a pathway for the substitution of interchangeable biologic drugs, a move applauded by Biotechnology Industry Organization (BIO).

pharmacy-4This week, Brown signed Senate Bill 671 into law, following recent passage in both the California Senate and Assembly. The legislation authorizes a pharmacist filling a prescription for a biologic medication to select an alternative, interchangeable biologic product, as long as the prescriber doesn’t indicate that no substitution is to be made.

In addition, within five days of being dispensed, the biologic prescription filled must be entered into an electronic system accessible by the prescriber. Substitution of a biologic product also must be communicated to the patient.

“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,” BIO president and chief executive officer Jim Greenwood said in a statement. “By signing this bill into law, Gov. Brown has added California to a growing list of states that allow retail pharmacies to substitute interchangeable biologic medicines.”

Greenwood noted that California’s approval of a pathway for interchangeable biologics is key, given the state’s status as a leader in biotech innovation and the fact that the move will give patients access to safe, effective therapies when the first interchangeable biologics are approved by the Food and Drug Administration.

“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,” according to Greenwood.

The FDA has approved biosimilar drugs for sale in the United States, but the agency is still working on the creation of a pathway for the development and approval of interchangeable biologics. As a result, policies on whether one product may be substituted in place of a doctor’s prescription and if a pharmacist must inform patients and physicians are covered by state law.

BIO reported that the FDA has indicated that it expects to see applications for the approval of interchangeable biosimilar products this year.

“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.”



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