The Biotechnology Industry Organization (BIO) and Pennsylvania Bio applauded the Pennsylvania Senate Public Health and Welfare Committee for its approval of Senate Bill 405, which in the event of any biologic product substitution would require a pharmacist to notify the patient and, within 72 hours, the patient's doctor.


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Pennsylvania bill requires notification in biologic substitution

November 14th, 2013

HARRISBURG, Pa. – The Biotechnology Industry Organization (BIO) and Pennsylvania Bio applauded the Pennsylvania Senate Public Health and Welfare Committee for its approval of Senate Bill 405, which in the event of any biologic product substitution would require a pharmacist to notify the patient and, within 72 hours, the patient's doctor.

BIO said Wednesday that Senate Bill 405, which now moves to the Senate floor for a vote, aims to preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies.

Biologic substitution has been a matter of debate because of questions about the interchangeability of drugs and inconsistencies in regulation. BIO noted that although the Food and Drug Administration oversees approval of biologic medicines and the designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must notify patients and doctors is covered by state law.

"BIO will continue to advocate for full transparency in the substitution process, as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy," BIO stated. "This bill is a model for legislation necessary in all 50 states to address this cutting-edge technology."

The FDA is in the process of creating a pathway for the development and approval of interchangeable biologic products in the United States.

BIO pointed out that interchangeability for biologics isn't the same as with conventional generic medications, because even slight changes to a biologic drug can change its properties entirely, making them different from the drugs they seek to substitute. For example, two biologics made using different cell lines and manufacturing processes will rarely, if ever, be exactly the same.

"Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances," BIO explained. "Providing notice to 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."

Last month in California, a veto by Gov. Jerry Brown illustrated ongoing issues with the introduction of biosimilars. Brown rejected Senate Bill 598, which would allow interchangeable biosimilar medications to be substituted for biologic medicines but also would require pharmacists to send prescribers notifications when a substitution is made in filling a prescription. Brown described the latter requirement as "premature."

BIO expressed disappointment with Brown's veto, in part because of the support it had garnered in the legislature.

"Senate Bill 598 received overwhelming bipartisan approval, passing 176-13 in five committees and three floor votes in the [California] Assembly and Senate and was supported by hundreds of patient advocate, physician, health care, biotech, labor and business groups," BIO stated. "The vetoed bill aligned with all five of BIO's principles on biologic substitution, properly preserved patient access to accurate prescription information, maintained incentives for innovation and promoted a competitive market for biologic therapies. The bill included full transparency in the substitution process — providing patients and their physicians the right to know what biologic medicine the patient receives from the pharmacy."

Still, Brown's veto of the bill was commended by the Generic Pharmaceutical Association (GPhA). The association noted that more than 30 organizations had urged Brown to reject the legislation, including CalPERS, the California Pharmacists Association, AARP, Walgreens, the California Retailers Association, the California Association of Health Plans, CVS Caremark, California Correctional Health Care Services, the Pacific Business Group on Health, Express Scripts and Kaiser Permanente. Opponents of the bill claimed it would add unnecessary burdens to the dispensing of biosimilars and hike costs.

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