The American College of Rheumatology (ACR) steadfastly supports the availability of safe and effective treatments for patients at the lowest cost possible, and underscores the necessity of scientific rigor for biosimilar use and approval.
The American College of Rheumatology (ACR) vehemently supports the availability of safe and effective treatments at the lowest cost possible to patients in a position statement presented by the Committee on Rheumatologic Care.
Following this introductory statement, the ACR emphasizes the necessity of sound science and the consideration of 6 observations and guiding principles that they outline in the position statement:
They recognize that due to the size, complexity, and heterogeneity of biologics, and therefore biosimilars, more scrutiny is needed in the evaluation of biosimilars compared with what might be needed for small molecule generics.
The ACR emphasizes the need for clinical data to make sure biosimilars are safe and effective, in addition to the necessary studies inherent to drug manufacturing. Additionally, they highlight that a record of long-term data on each biosimilar is necessary to monitor for less common but still critical adverse events.
They speak on the necessity of long-term monitoring for children and adults: “Postmarketing surveillance studies are needed in children, as well as adults, as toxicities and long-term sequelae may be different in these disparate populations. The Best Pharmaceuticals for Children Act, which reauthorizes the pediatric studies provision of the FDA Modernization and Accountability Act to improve safety and efficacy of pharmaceuticals for children, should apply to biosimilars.”
They call for more clear FDA labels (package inserts) to indicate if a biosimilar is interchangeable with the reference biologic, and that these labels should clarify all approved biosimilar indications. Also, they require specification on if the data for the indication is taken from studies of the biosimilar or the reference biopharmaceutical.
Additionally, if health care providers choose a medication that has a biosimilar option for a patient, the ACR supports the use of a biosimilar first.
In position 6, the ACR highlights their opposition to forced biosimilar switching by insurers:
“In patients on established therapy, the final decision to switch from a reference product to a biosimilar should rest with the prescriber and the patient. The ACR opposes insurer-mandated forced switching to biosimilars and is concerned over frequent nonmedical switching with biosimilars. In jurisdictions where substitution by someone other than the prescribing provider is lawful, the prescribing provider and the patient should be notified immediately when a substitution is made.”
The ACR recognizes that because biologics are so complex, they are expensive, and incite worry about the financial sustainability of the health care system and patients. They agree that biosimilars can help reduce the burden of cost if providers and patients can receive reassurance that they are safe and effective following rigorous scientific study of the products.
For more information on the 6 positions, read the full statement.