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WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.
McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.
It would also require the pharmacist to inform the patient before dispensing and record the name of the product and its manufacturer on the dispensing record and prescription label. In addition, pharmacists would be required to provide cost information for the reference product and the biosimilar to the patient.
While praising the bill's sunset clause, saying it meant the bill would likely expire before any Food and Drug Administration-approved biosimilar became available, the Generic Pharmaceutical Association, a trade group that represents generic drug companies, criticized the bill.
“The law signed today in Virginia to allow for the substitution of biosimilars in that state, while well intentioned, is pre-emptive, and carries burdensome administrative ‘red tape’ that threatens the positive impact biosimilars will have in Virginia," GPhA president and CEO Ralph Neas said.
Similar laws have been working their way through the legislatures of other states, such as Colorado and Florida, and could stand in the way of full implementation of the biosimilar approval pathway that passed as part of the Patient Protection and Affordable Care Act. While the healthcare-reform law created the conditions for an abbreviated pathway for biosimilars, similar to the one created for generic drugs with the Hatch-Waxman Act of 1984, it is up to the FDA to create the specific regulations, which the agency is still in the process of doing.
Biotech companies have supported the state laws, saying they are necessary to promote patient safety. They say that unlike generic drugs, which are required to be identical to their branded counterparts, slight changes to a biologic drug — such as generic differences between the cell lines used by the creator of an original biologic and those used by the creator of a biosimilar — can dramatically change its properties and therefore its safety and efficacy profile.
But generic drug companies, which strongly backed the abbreviated pathway for biosimilars, dispute the biotech industry's view.
"The push for these new measures has nothing to do with safety and everything to do with Amgen and Genentech, two biotech Goliaths, trying to thwart competition," Neas said.