Biologics are the fastest growing and the most expensive class of drugs on the market. The current cost of biologics is between $50,000 to $250,000 for one year of treatment. FTC Press Release. The numbers are expected to increase even further. Congressional Research.
Biosimilars –on the other hand – are less expensive due to their generic-like nature. Biosimilars are marketed after patents have expired on the original biopharmaceutical product. They are, however, not generic versions of biologics, which are complex, large molecules that are genetically engineered in a highly controlled environment. Because different cells are used to produce a biosimilar version, the end product is different. And in biologic medicine, even a small difference can be crucial to the end product’s clinical effect and safety. Yet, biosimilars are chemically close enough to already approved biopharmaceuticals and their cost of manufacturing is lower (the manufacturers can rely on the already existing scientific knowledge about the safety and effectiveness of the biopharmaceutical).
Therefore, the idea of expediting and increasing availability of biosimilars is very attractive for the policymakers. In addition, a recent U.S. Supreme Court decision held that a biosimilar manufacturer may enter the market faster than a biopharmaceutical manufacturer and may use various shortcuts in a long path of a new drug application process. Sandoz v. Amgen.
Specialty pharmacies are definitely affected by the introduction of biosimilars because most biologics are dispensed through a specialty pharmacy system. Specialty pharmacies’s four largest biopharmaceuticals are erythropoietin, recombinant DNA insulin, human growth hormone, and granulocyte colony stimulating factors. But the transition to biosimilars might not be all smooth for specialty pharmacy. First of all, the availability of biosimilars will depend upon the prescriber’s determination of whether to switch the patient to a biosimilar product. A pharmacist may substitute a generic drug when presented with a prescription for its brand equivalent, unless a physician or patient specifically requests the brand name drug. However, these state substitution laws do not apply to biosimilars. Some states have enacted such substitution provisions, including Florida, North Dakota, Oregon, Utah, and Virginia (Fla. Stat. § 465.0252; N.D. Cent. Code § 19-02.1-14.3; Ore. Rev. Stat. § 689.522; Utah Code § 58-17b-605.5; Va. Code § 54.1-3408.04.) California’s biosimilar substitution law was subsequently vetoed by the governor (but the law allows for interchangeable biologics substitution). Therefore, pharmacies should work closely with the prescribers to determine whether a biosimilar may suit the patient.
Improved availability and lower cost may reduce pharmacies’ acquisition costs and increase sources of revenue. Patients are also likely to have more options of the products available as well as the number of pharmacies that can serve their needs. Currently, biologics manufacturers supply their products only to very limited distribution channels. Biosimilar manufacturers are likely to make products available to a wider network of specialty pharmacies. But ultimately, time will show how biosimilars affect pharmacies, payors, and patients.
An excellent overview of Biosimilars: “Where are all the Generic Biopharmaceuticas (Follow-op Biologics)? (And how much money will they save?)” by Laura A. Carpenter, RPh, JD.