Improved Insurance Coverage Increased Biosimilar Semglee's Market Share After The FDA's Interchangeability Designation.

Although biosimilars have potential to reduce drug spending, their use remains low. Automatic substitutions of biologic drugs by their biosimilars at pharmacies can facilitate biosimilar uptake. Yet, state regulations limiting the types and circumstances under which biosimilars may be substituted could discourage efficient biosimilar adoption. To examine associations of state substitution laws in the US with biosimilar adoption in the insulin glargine market, in which an interchangeable biosimilar was recently launched. This retrospective cohort study using MarketScan commercial claims data examined fills for insulin glargine among users who were younger than 65 years and had fills for the insulin glargine Lantus (Sanofi) and its biosimilars, interchangeable insulin glargine-yfgn (Semglee [Mylan Pharmaceuticals]) and a noninterchangeable insulin glargine (Basaglar [Lilly]). Data were analyzed from August 2024 to January 2025. Market share of the insulin glargine, interchangeable insulin glargine-yfgn, and the noninterchangeable insulin glargine. Unit of analysis was the per-person prescription fill. Changes in fills between those residing in states with less vs more restrictive substitution laws in a 1-year period before and after the launch of interchangeable glargine-yfgn (November 16, 2021) were compared. A total of 487 281 per-person prescription fills (mean [SD] age, 49.5 [13.3] years; 56.9% male) were included, with 158 141 and 329 140 per-person prescription fills from less vs more restrictive states, respectively. Following the launch of insulin glargine-yfgn, its market share differentially increased by 7.03 percentage points (pp; 95% CI, 1.89-12.18 pp; P = .008), coinciding with a 6.48 pp (95% CI, -11.70 to -1.26 pp; P = .02) differential reduction in the insulin glargine market share in states with less vs more restrictive laws. In the last quarter, the market share for insulin glargine-yfgn was 20.6% and 12.1% in states with less and more restrictive laws, respectively. There were not statistically significant differential changes in fills for the noninterchangeable insulin glargine (-0.24 pp; 95% CI, -1.40 to 0.92 pp; P = .68). Three restrictions had more pronounced associations with a lower uptake of insulin glargine-yfgn: enhanced physician notification (-8.15 pp; 95% CI, -12.49 to -3.81 pp; P < .001), refill notifications (-4.68 pp; 95% CI, -8.78 to -0.58 pp; P = .03), and patient notification (-3.52 pp; 95% CI, -8.44 to 1.40 pp; P = .16). In this cohort study, insulin users in states with less restrictive substitution laws were more likely to fill the biosimilar alternative to insulin glargine, underscoring the role of state regulations of substitution as an important determinant of biosimilar adoption and the need for reforms to increase efficient biosimilar adoption.

New Medications for the Treatment of Diabetes.

New insulins and insulin therapy

Journal of Diabetes News

Successful Investigational New Drug Preparation without Reinventing the Wheel

The first US Food and Drug Administration-approved interchangeable biosimilar designation-that for insulin glargine-occurred in 2021, enabling pharmacy substitution for the branded originator. However, the impacts of this interchangeable designation on prescription dispensing are unknown. To assess impacts of the transition of Semglee to interchangeable designation on prescription dispensing. This economic evaluation analyzed changes in insulin glargine dispensing before and after the introduction of the interchangeable designation using data collected from IQVIA's National Prescription Audit, a nationally representative comprehensive database of pharmacy dispensing for the US, and PayerTrak. Data cover the time period from September 2019 through June 2024 and were analyzed from June 2023 to December 2024. Any medical diagnosis that would make insulin glargine a relevant treatment. The primary outcomes were monthly US aggregate pharmacy dispensing of Semglee and insulin glargine-yfgn, measured both in prescription counts (in thousands of prescriptions) and as a proportion of the US aggregate insulin glargine market. Results were disaggregated into Semglee and insulin glargine-yfgn to show that changes in dispensing were associated with the interchangeable designation even after accounting for Semglee's formulary changes. This evaluation additionally examined dispensing channel and payer type. After the introduction of interchangeable Semglee and insulin glargine-yfgn in November 2021, there was a discontinuous increase in aggregate Semglee/insulin glargine-yfgn dispensing of 47.41 (95% CI, 19.45-75.38; P = .001), suggesting that the interchangeable designation was associated with substantially increased utilization. In addition, Semglee and insulin glargine-yfgn's share of the total insulin glargine market matched its dispensing trends, demonstrating that the jump in dispensing was not associated with changes in the market as a whole. When disaggregating by channel, there were also statistically significant increases in all 3 channels: retail (20.27; 95% CI, 2.58-37.95; P = .03), mail (6.63; 95% CI, 3.58-9.67; P < .001), and long-term care (20.52; 95% CI, 11.06-29.98; P < .001). This jump, however, coincided with advantageous formulary changes for Semglee but not insulin glargine-yfgn, the increased utilization of which was still associated with the interchangeable designation. In the Medicare Part D, Medicaid, and cash channels, insulin glargine-yfgn adoption grew faster than Semglee, reaching higher levels of dispensing in every single period measured after launch. In this economic evaluation, the first US Food and Drug Administration approval of interchangeable status was associated with increased dispensing of the follow-on. This suggests that interchangeability designation may play an important role in decreasing costs and increasing access to biosimilar prescription drugs for patients.

“Black box” 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk

The future of drug safety: What the IOM report may mean to the emergency department

Research round-up

British chef and food activist Jamie Oliver ignited a firestorm in January 2011 when he mentioned on the Late Show with David Letterman that castoreum, a substance used to augment some strawberry and vanilla flavorings, comes from what he described as “rendered beaver anal gland.”1 The next year, vegans were outraged to learn that Starbucks used cochineal extract, a color additive derived from insect shells, to dye their strawberry Frappuccino® drinks2 (eventually, the company decided to transition to lycopene, a pigment found in tomatoes3). Although substances like castoreum and cochineal extract may be long on the “yuck factor,”4 research has shown them to be perfectly safe for most people; strident opposition arose not from safety issues but from the ingredients’ origins. But these examples demonstrate that the public often lacks significant knowledge about the ingredients in foods and where they come from. This is not a new development; the public relationship to food additives has a long history of trust lost, regained, and in some cases lost again. The Federal Food, Drug, and Cosmetic (FD&C) Act of 19385 was passed shortly after the deaths of 100 people who took an untested new form of a popular drug, which contained what turned out to be a deadly additive.6 The new law was consumer oriented and intended to ensure that people knew what was in the products they bought, and that those products were safe. The law has been amended over the years in attempts to streamline and bring order to the sprawling task of assessing and categorizing the thousands of substances used in foods, drugs, and cosmetics. One result of this streamlining is that under current U.S. law, companies can add certain types of ingredients to foods without premarket approval from the thin-stretched Food and Drug Administration (FDA). In other words, there are substances in the food supply that are unknown to the FDA. In 2010 the Government Accountability Office (GAO) concluded that a “growing number of substances … may effectively be excluded from federal oversight.”7 Is this a problem? The answer depends on whom you ask.

(Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus.

(Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …

The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar approvals over the years, biosimilar adoption in the United States has been slow and gradual, largely driven by payers rather than clinicians. In order to better understand the barriers to biosimilar adoption in the clinic, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M‐CERSI) and the FDA jointly hosted a virtual workshop on April 13, 2022, titled “Biosimilars: A Decade of Experience and Future Directions – Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology.” This summary documents the experiences of four leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology and their perspectives on how to increase biosimilar adoption, including the role of clinical pharmacology. Besides systemic changes in pricing and reimbursement, there is a need for additional education of a broad range of providers, including advanced care practitioners, and patients themselves. Educational efforts highlighting the rigor of the studies that support the approval of biosimilars—including the clinical pharmacology studies—and the benefits of biosimilars, can play a major role in improving biosimilar acceptance.

The US Food and Drug Administration (FDA) is a remarkable hybrid. Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy. The FDA’s mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions. Both fall under the rubric of protecting and promoting the public health. The FDA’s remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy. The products it is charged with overseeing through its various centers1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively). Tobacco products were added to the FDA’s portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products. Regardless of the specific product regulated, the FDA’s core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians. At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner. Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation. At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might …