The prevalence of biologic drugs has led to the demand for “generic” alternatives of these products. The Biologics Price Competition Innovation (BCPI) Act enacted as part of the Affordable Care Act amended the Public Health Services Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar and interchangeable. Importantly, “Biosimilarity” and “interchangeability” are not equivalent; a drug can qualify as biosimilar but not be interchangeable. According to the FDA, a product with biosimilarity “is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences in terms of safety, purity and potency of the product.” In order for a drug to be considered interchangeable, however, there must be evidence that the product is expected to produce the same clinical result as the reference product in any given patient. Additionally, the drug must demonstrate that the safety or reduced efficacy risk of alternating or switching the reference product to the alternative is not greater than the risk of using the reference product.
Recently, the FDA unveiled its draft guidance on biosimilar product labels, which will rely heavily on their reference products’ labels. The FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demonstration that there are no clinically meaningful differences between the proposed biosimilar and the reference product. The FDA states “data from clinical studies designed to support a demonstration of biosimilarity are not likely to be relevant to a health care practitioner’s considerations regarding safe and effective use of the biosimilar product and potentially may cause confusion, resulting in an inaccurate understanding of the risk-benefit profile of the products.” This notion is exemplified if the “endpoints used in a clinical study intended to support demonstration of no clinically meaningful differences may not be the same end points studied to support approval of the reference product and may not inform prescribing decisions regarding safety and efficacy.” The FDA says that like with generics, biosimilar labeling should include a description of the clinical data that supports safety and efficacy of the referenced product. However, in circumstances where a biosimilar is not approved for the same indications as the referenced product, unlike with generic drugs, the FDA notes that “it may be necessary to include information in the biosimilar product labeling relating to an indication for which the biosimilar product applicant is not seeking licensure in order to help ensure safe use.”
The interplay between biosimilar product labeling and clinical practice is evident as demonstrated by the State of New Jersey’s statute, that went into effect January 1, 2016, describing the scope of pharmacist authority to substitute between biologic products. The statute states that a pharmacist may substitute a biological product for a prescribed biological product when the authorized prescriber has not indicated that there shall be no substitution, and the biological product to be substituted is FDA-approved to be interchangeable with or therapeutically equivalent to the prescribed biological product. Pharmacists will then be required to notify the patient in writing that the biological product dispensed has been approved by FDA as an interchangeable biosimilar biological product for the prescribed biological reference product; notify the prescriber (via written, telephonic, or electronic notification), within five business days, of the specific product provided to the patient, including the name of the product and the manufacturer; and record on the prescription label and record of dispensing the product name and manufacturer of the biological product dispensed, followed by the words “Substituted for” and the name of the prescribed biologic. Pharmacists who meet these requirements in dispensing and substituting a biological product for its reference product would incur no greater liability for dispensing the substituted product than would be incurred for dispensing the prescribed product.
As the field of biosimilars evolves, it will be increasingly important for the pharmacist to be aware of the FDA and States’ Board of Pharmacy rules on biosimilarity and interchangeability. Frier Levitt has substantial experience in advising pharmacies on issues related to compliance with federal and state pharmacy laws and regulations, contact us today to speak with one of our attorneys.
