Exactly what pharmacists will have to do to meet state regulations when dispensing a new class of drugs — and whether that’s a necessary step to increase the safety of patients or a waste of money — has moved to the center of an ongoing legislative lobbying battle.
A bill that would require pharmacists to notify doctors and other prescribers when they substitute a class of drugs known as biologics with substitutes called biosimilars is currently being debated in the state legislature.
Biologics are cultivated from living cells, unlike traditional drugs, which are synthesized in labs. This difference in chemistry means that each biologic is unique, according to industry representatives who argue that’s a key reason why doctors should know each time a pharmacy makes a substitution of a biosimilar for a biologic. Biosimilars are akin to name-brand biologics, but cheaper. While the government is expected to certify that some biosimilars are interchangeable with biologics, they won’t be chemically identical in the same way that generic drugs can be identical to name-brand drugs.
The bill, A-2477/S-1705, is supported by the biotechnology industry, which sees these notices as a necessary step to ensure that doctors are aware that a substitution has been made.
Bill sponsor Assemblywoman Pamela R. Lampitt (D-Burlington and Camden) said the measure would allow the introduction of biosimilars while protecting patients.
“This is about patient safety,” she said. “This is about a physician, a prescriber, knowing which product has been dispensed to their patient.”
However, some pharmacy groups see this step as a potential barrier to making substitutions, since it will take additional time, and unnecessary, because the substitutions will only be made if the Food and Drug Administration has certified that the potential substitute is interchangeable with the original prescription. They’d like the process to be similar to an existing one for generic drugs, where the onus is on the doctor to access a computer system to see if a substitution was made.
Lampitt is trying to stay ahead of the issue, since the FDA hasn’t certified that any biosimilars as being interchangeable with existing biologics. But they have been in Europe and the Affordable Care Act required that states establish processes so that they could be dispensed once they meet FDA approval. In addition, the FDA recently approved a biosimilar developed by Novartis’sSandoz unit, which is a step toward it being considered as interchangeable.
The issue of how they’re dispensed is particularly important in New Jersey, where the biotechnology sector — which makes biosimilars — has grown while the overall pharmaceutical industry has shrunk.
Debbie Hart, president and CEO of biotech industry group BioNJ, said the safest approach would be to require pharmacies to call substitutions to the attention of doctors.
Biologics “literally can’t be replicated, there are so many different parts of the process that defy reproducibility,” Hart said, adding that: “At the end of the day, it’s all about patient safety.”
That’s an assertion that’s called into question by John Holub, executive director of pharmacy trade group the New Jersey Council of Chain Drug Stores.
Holub said opposition to a simpler substitution process by makers of biologics is rooted in the amount of money that industry makes off of the products. With billions of dollars in biologic patents coming ending in the next several years, these companies want to block competition, he said.
“There’s no reason to treat these drugs any differently,” than generic drugs, since the FDA will be applying a higher level of scrutiny to determine whether a biosimilar is interchangeable with a biologic product, he said.
Holub said he was encouraged that Lampitt dropped a provision from the bill that would have required pharmacists to tell patients when they’re making substitutions. He noted that patients are already informed of changes through the label to their prescriptions.
The potential for lost profits “is why they want to create these barriers and these roadblocks to prevent these drugs from being substituted,” Holub said.
[related]Pharmacy industry representatives said they remain hopeful that Lampitt will agree to further amend the bill.
Hart added that the bill is important for the biotech industry, which is where growth in pharmaceuticals is increasingly concentrated. Biotech has grown as a share of the overall pharmaceutical industry in New Jersey. Biotech firms employ 41,795 people, or 36 percent of pharmaceutical jobs in the state.
“It is the one area of the economy that has been consistently growing in New Jersey, despite the economy and the recession, despite the challenges in big pharma,” Hart said.
New Jersey doesn’t have quite the same leadership role in biotech that it traditionally had in pharmaceuticals. While it has long had the second-largest pharmaceutical industry in the country, behind only California’s, it trails both California and Massachusetts in the number of recent bioscience-related patents, as well as California, Massachusetts, and Texas in bioscience venture capital investment, according to an industry report.
The broader pharmaceutical industry, individual companies, and groups that advocate for treatments for specific diseases joined BioNJ in endorsing the bill.
The Assembly Health and Senior Services Committee released the bill on a unanimous 12-0 vote last week.