The non-medical switching of prescription medications.

Non-medical switching of medication, whereby a patient's treatment regimen is changed for reasons other than efficacy, side effects, or adherence, is often related to drug formulary changes aimed at reducing drug costs. In the era of health care reform, while cost-cutting measures are important, there is considerable evidence that non-medical switching, particularly when applied to medication used to treat chronic conditions such as diabetes, may impact patient outcomes, medication-taking behavior, and use of health care services. Ultimately, overall costs may be increased, as savings by insurers are cancelled out by higher costs to the health care system as a whole, such as extra administration, treatment failure from new medicines, and increased adverse events. The emergence of biosimilar and follow-on biologic treatments raises further questions among patients receiving biologic treatments, with patient advocacy groups calling for clear legislation to ensure that patients with complex or chronic conditions continue to receive effective, evidence-based medications for their disease. This article will discuss non-medical switching in the US, taking into account the different parties involved, such as patients, health care providers, pharmacists, payers, and pharmacy benefit managers, with the aim of providing a detailed overview of this complex and evolving topic.

A GUIDE TO FOLLOW-ON BIOLOGICS AND BIOSIMILARS WITH A FOCUS ON INSULIN.

OBJECTIVE: Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system. METHODS: Literature has been reviewed to provide information on various aspects of biosimilars and a follow-on biologic of insulin. This will include structure, efficacy, cost, switching, and legal issues. RESULTS: Biologic products are large, complex molecules derived from living sources. Follow-on biologics are copies of the original innovator biologics. It is not possible to copy their structure exactly, leading to possible differences in efficacy and safety. Thus, regulations involving biologics are complex. Follow-on biologics are regulated under two Federal laws until March 23, 2020: the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act. Biosimilars are follow-on biologics which have been approved via the PHS Act. They consist of those which are "highly similar" to the reference drug and those which are "expected" to produce the same clinical result as the reference drug (interchangeable biosimilars). Interchangeable biosimilars have been determined by the U.S. Food and Drug Administration to be substitutable by the pharmacist "without the intervention" of the prescriber. From the patient perspective, switching to a follow-on biologic may necessitate a change in delivery device, which may create issues for patient adherence and dosing. CONCLUSION: Although they present several challenges in terms of regulation and acceptance, follow-on biologics have the potential to significantly reduce costs for patients requiring insulin therapy. ABBREVIATIONS: BLA = biologics license application EU = European Union FDA = Food and Drug Administration FD&C = Food, Drug, and Cosmetic HCPCS = Healthcare Common Procedure Coding System INN = internatinal nonproprietary name NDA = new drug application PHS = Public Health Service.

Impact of Biosimilar Insulins on Clinical Practice: Meeting Report.

The availability of biosimilar insulins can potentially lead to lower insulin costs and increased access for patients with diabetes, worldwide. However, clinicians and regulatory agencies have raised several concerns regarding the safety and efficacy of these new medications. The European regulatory agencies have established guidelines for market approval of biosimilar insulins; however, many issues remain unresolved. Moreover, although the FDA has developed preliminary pathways for biosimilar protein development and is prepared to review each application on a case-by-case basis, insulins do not fall under this pathway at this time. The development of effective postmarketing surveillance protocols, determination of product interchangeability, and product identification/labeling remain key concerns. Numerous issues surround the development and commercialization of biosimilar insulins; thus, it is important that all stakeholders fully understand the complexity of these issues and how they can potentially affect patient care. Bridging the educational gap among clinicians and regulatory agencies will be challenging but necessary for ensuring patient safety.