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Bipartisan legislation introduced in March (House Bill 195) would allow pharmacists in North Carolina to substitute “biosimilar” medicines for conventional medicines prescribed by a physician. Biosimilars are drugs that have been proven to be as safe and as effective as the original drugs (called “biological” drugs) but cost significantly less. These lower costs would be passed on to the patient, saving consumers money. North Carolina is one of the top pharmaceutical producers in the country.
Under the proposed legislation, if it is shown that the biosimilar drug has the equivalent therapeutic properties (such as active ingredient, strength, quantity, and dosage) as the original biological drug, the biosimilar drug could then be substituted by the pharmacist (unless the physician specifies in writing on the prescription that only the named biological medicine can be dispensed to the patient and may not be substituted with a biosimilar medicine). It works the same way now for name-brand versus generic medications.
The legislation passed the house by a huge margin (103 to 10) on April 2 and now awaits action in the Senate.
There are three categories of drug products that can be used in the prevention, treatment, or cure of a disease or condition of human beings, according to Public Health Service Act, 42 U.S.C. § 262(i):
- Biologics. Biologic medicines are much more complex than traditional chemically synthesized drugs. Biologics are manufactured from living organisms by programming cell lines to produce the desired therapeutic substances and consist of large molecules. Common biologics in use today include human growth hormone, injectable treatments for arthritis and psoriasis, the Hepatitis B vaccine and stem cell therapy.
- Biosimilars. Biosimilars carry out the same functions as their counterparts but are not chemically identical, as would be a generic drug. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
- Interchangeables. Interchangeable biologics must produce the same result in any given patient, and without negative effects, in terms of safety or efficacy, from switching between the reference product and interchangeable biosimilar. The Biologics Price Competition and Innovation Act states that interchangeable biologics may be substituted without the intervention of the healthcare provider. This high standard renders any additional state protections unnecessary and potentially burdensome.
According to National Conference of State Legislatures, at least 23 states have considered legislation over the past two years establishing state standards for substitution of a biosimilar prescription product to replace an original biologic product.
“Biosimilars are less expensive to manufacture, require less development time than originator biologics and are proven to be just as safe and effective,” said Marty Nealey, vice president of operations and plant manager at Hospira’s Rocky Mount Facility. “They’re new to the United States, available as biologic patents expire,” said Mr. Nealey in an editorial in the Raleigh News & Observer. “But patients in Europe, Australia and elsewhere have used them safely and effectively for years.”
“The purpose of this bill is to get on the cutting edge of innovation in the pharmaceutical, biotechnology world to prepare our state for what will be a burgeoning market in biosimilar and interchangeable treatments,” said Representative Nelson Dollar, the bill’s primary sponsor. “This is going to be a boon for physicians, for patients, to be able to access these types of treatments as they are approved by the FDA. The benefits of this legislation are potentially enormous. Savings for patients in the healthcare system nationally are estimated by the Rand Corporation to be $44.2 billion over 10 years.”
Representative Susan Martin, one of the bill’s primary co-sponsors, also spoke in favor of the bill. “This is a ‘jobs bill’ for North Carolina because, as you know, the pharma industry and biopharmaceuticals are a huge segment for North Carolina,” she remarked when speaking in support of the bill on the floor of the House. “We’re one of the top producers in the country. The first biosimilar that’s been approved by the FDA, which was on March 6th, which was the first time this product was approved, is manufactured in Wilson at Sandoz, and they are a division of Novartis, who have the most biosimilars in the world. So this is innovation taking place and a lot of the innovation and research is taking place in North Carolina and we want to promote that.”
“Lawmakers have an exceptional opportunity this year to improve health care for hundreds of thousands of North Carolinians, reduce treatment costs and promote our state’s growing life sciences industry, all in one bill,” concluded Mr. Nealey.