HARRISBURG -- Generic prescription drugs, commonplace for decades, are now a $90 billion industry in the United States. Yet certain medications used to treat serious conditions -- including cancer and lupus -- are made from living material, such as blood and proteins. They have no generic equivalents.
But the Affordable Care Act of 2010 gave the U.S. Food and Drug Administration a new pathway to license biological medications that are highly similar to ones already on the market. Now, in states including Pennsylvania, lawmakers are considering regulations that would govern how pharmacists can substitute medications deemed by the FDA to be interchangeable with existing biological drugs.
The extent to which pharmacists dispense interchangeable biosimilars -- the way they now substitute brand-name, small-molecule drugs with less expensive generics -- will shape a market that holds the potential for great profit.
The FDA has yet to approve a single biosimilar medication. But last year, seven of the top 10 best-selling pharmaceuticals worldwide were expected to be biologics, according to Sandoz, the generic pharmaceuticals division of Novartis.
That potential has led to great interest in how biosimilar medications will reach patients.
"We've got big pharma against new pharma, and we've got chain stores and drugstores and pharmacists, everyone involved in this process," House Health Committee Chairman Matt Baker, R-Tioga, said last week at a crowded hearing on one proposal. "We're trying to find a pathway by which we can find some agreement and move forward."
Chain drugstores, health insurers and generic drug makers registered their opposition to the House bill, sponsored by state Rep. Bryan Cutler, R-Lancaster, which would require the person presenting a prescription to consent in writing to the substitution, the pharmacist to notify the prescriber in writing within 72 hours of dispensing the medication and the pharmacy and prescriber to keep a written record of the substitution for at least five years. (The provisions are also part of a Senate bill sponsored by state Sen. Pat Vance, R-Cumberland.)
State law on generics, which does not address biosimilars, requires pharmacists to notify a purchaser, but not to ask for their written consent. Physicians can note that a brand-name drug must be dispensed as prescribed.
"Legislation like this is a typical brand ploy to thwart competition," said Brynna Clark, senior director of state affairs at the Generic Pharmaceutical Association, in a letter to the House Health Committee.
Generics made up 84 percent of prescriptions dispensed in the United States in 2012, accounting for 28 percent of total spending on pharmaceuticals that year, more than $90 billion, according to IMS Institute for Healthcare Informatics.
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.state - health
Karen Langley: firstname.lastname@example.org or 717-787-2141.