Proponents say state-level regulations are appropriate because, unlike generic drugs, even those biological medications deemed interchangeable by the FDA can differ from the original product.
To receive approval for a medication as a biosimilar, manufacturers have to show that their product is highly similar to the original biological medication. It cannot differ in any "clinically meaningful way" in its safety, purity or potency. But pharmacists still cannot substitute for a brand-name medication unless the FDA also deems the biosimilar to be interchangeable.
For that to happen, the manufacturer must also show the treatment is expected to have the same effect as the original medication on any patient. For drugs that are given more than once, the maker has to show that switching between the biosimilar and original drug is no more risky than continuing to take the original drug.
But a representative of the Biotechnology Industry Organization, which represents 1,100 biosciences companies, said that while the FDA will ensure biosimilars are safe and effective, physicians still should be notified of substitutions, since medicines derived from cell lines will not be exactly the same as the drugs they replicate.
Fritz Bittenbender, BIO's senior vice president of external affairs, said the body can build up an immune response to treatments, so physicians should be told if a substitution occurs.
Patient advocacy groups, such as the regional chapter of the Lupus Foundation of America, support the legislation, which they say offers protection to recipients of the drugs.
Last Wednesday, on the day of the hearing, the board of the Pennsylvania Medical Society agreed to support the proposals, with one caveat: Rather than requiring pharmacists to notify prescribers of a substitution within 72 hours after the fact, the board agreed prescribers should be notified 24 hours beforehand.
Such a change in the timing requirement "gives the physician the opportunity to change it if they think that's necessary," said Dr. Karen Rizzo, vice president of the medical society.
State regulation of biosimilars has been the subject of 30 bills or resolutions this year, according to the National Conference of State Legislatures. Proposals in five states -- Florida, North Dakota, Oregon, Utah and Virginia -- have become law, while California legislators have sent a bill to the governor.
While the FDA has not approved any medications as biosimilars, its Center for Drug Evaluation and Research as of earlier this month had received 57 requests for initial meetings to discuss developing biosimilars for 13 different brand-name medications, according to Sandy Walsh, an agency spokeswoman. The agency had held 47 initial meetings.
The FDA does not take a position on state legislative proposals, Ms. Walsh said in an email, but she added that "Congress deliberately set a very high bar for a biosimilar product approval."
Ms. Walsh said the ability to substitute spurred the growth of the generic drug industry and will foster competition in the biologic drug market.
"Ultimately, such competition will spur innovation, improve consumer choice and drive down medical costs," she said.
Karen Langley: firstname.lastname@example.org or 717-787-2141.
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