Accelerating biosimilar market access: the case for allowing earlier standing

Biosimilars, which are affordable alternatives to biologic medicines, face delays in market entry due to the current patent litigation framework under the Biologic Price Competition and Innovation Act. Currently, biosimilar manufacturers can only initiate patent litigation to attempt to clear weak and invalid patents after submitting their Biologic License Application to the Food and Drug Administration (FDA), which happens after completing extensive, and costly clinical trials. By contrast, generic drug manufacturers can start litigation earlier due to shorter development times and less stringent clinical requirements, allowing them to launch immediately after the primary patent expires. We propose allowing biosimilars to begin patent litigation at the start of phase 3 clinical trials, the final stage of biosimilar development, where the product and manufacturing process and product profile are largely finalized. This change would enable biosimilar firms to resolve patent issues well before the brand biologic\u27s primary patent expiration date, potentially reducing market entry delays by about 1.8 years. This article examines the issues surrounding initiation of biosimilar litigation and suggests litigation reforms to expedite biosimilar market availability

An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection

Introduction: Each year, people with diabetes and their insurers or governments spend billions of dollars on blood glucose monitors and their associated components. These monitors have evolved substantially since their introduction in the 1970s, and manufacturers frequently protect original medical devices and their modifications by applying for and obtaining patent protection. Research design and methods: We tracked the product iterations of five widely used blood glucose monitors-manufactured by LifeScan, Dexcom, Abbott, Roche, and Trividia-from information published by the U.S. Food and Drug Administration (FDA), and extracted relevant U.S. patents. Results: We found 384 products made by the five manufacturers of interest, including 130 devices cleared through the 510(k) pathway, 251 approved via the premarket approval (PMA) pathway or via PMA supplements, and three for which de novo requests were granted. We identified 8095 patents potentially relevant to these devices, 2469 (31%) of which were likely to have expired by July 2021. Conclusions: Manufacturers of blood glucose monitoring systems frequently modified their devices and obtained patent protection related to these device modifications. The therapeutic value of these new modifications should be critically evaluated and balanced against their additional cost. Older glucose monitoring devices that were marketed in decades past are now in the public domain and no longer protected by patents. Newer devices will join them as their patents expire. Increased demand from people with diabetes and the health care system for older, off-patent devices would provide an incentive for the medical device industry to make these devices more widely available, enabling good care at lower cost when such devices are substantially equivalent in effectiveness and safety. In turn, availability and awareness of older, off-patent devices could help stimulate such demand.</p

Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases

Abstract Neovascular age-related macular degeneration (AMD) is a progressive eye disease and is a leading cause of vision loss in the Western world. Vascular endothelial growth factor inhibitors have become a mainstay of treatment for this disease. Currently, treatment options include three originator biologics with approvals for neovascular AMD (aflibercept, ranibizumab, and brolucizumab-dbll) and one biologic that is commonly used off-label for the condition (bevacizumab). In the USA, Medicare spending on these drugs consistently surpassed $4 billion per year between 2015 and 2019, driven by high prices and varying off-label use of bevacizumab, which is substantially cheaper than the other biologics used to treat neovascular AMD. In this article, we discuss how legal reform can improve market competition for biologic drugs, using AMD therapies as a case study. We chose this group of drugs for their significant contribution to Medicare spending, the price difference between approved therapies and intravitreal bevacizumab, and because there currently exists a large biosimilar pipeline with many drug candidates in the final stage of development. We propose mechanisms for anticipating and facilitating the market introduction of biosimilars, as well as changes to the pricing model in Medicare that can promote use of cost-effective therapies. Reforms such as empowering Medicare to negotiate drug prices may help ensure that introduction of new biologics and biosimilars for AMD will lower spending and increase patient access.</jats:p

Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions

IMPORTANCE: Brand-name drugs, including biologics, have been the primary source of increasing prescription drug spending in the US. Each state has drug product selection laws that regulate whether and how pharmacists can substitute prescriptions for brand-name drugs with more affordable equivalents, either small-molecule generic drugs or interchangeable biologics, but the details of these laws can vary. OBJECTIVE: To examine the variation in state drug product selection laws with regard to factors that may affect which version of a drug is dispensed. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional analysis was performed, using a legal database, to obtain information on state laws of all states plus Washington, DC, as they existed on September 1, 2019. EXPOSURES: Whether substitution was mandatory or permissive, patient consent was needed prior to substitution, patient notification of substitution was required independent of the drug’s packaging, and/or pharmacists were protected from special risk of liability for substitution. MAIN OUTCOMES AND MEASURES: For small-molecule and biologic drugs, descriptive statistics were generated for the 4 exposure variables. In addition, for small-molecule drugs, a generic substitution score with a maximum of 1 point was assigned for each exposure variable (range, 0-4 points), with higher scores indicating regulatory requirements limiting substitution. RESULTS: This cross-sectional analysis of the generic drug substitution regulations in the 50 US states and Washington, DC, found that for small-molecule drugs, 19 states required pharmacists to perform generic substitution; 7 states and Washington, DC, required patient consent; 31 states and Washington, DC, mandated patient notification independent of the drug’s packaging, and 24 states did not explicitly protect pharmacists from greater liability. Nine states and Washington, DC, had a generic substitution score for small-molecule drugs of 3 or higher, and 45 states had more stringent requirements for interchangeable biologic substitution, most commonly mandatory physician notification. CONCLUSIONS AND RELEVANCE: The findings of this study suggest that there is a need for optimizing state drug product selection laws to promote generic and interchangeable biologic substitution, which may help improve medication adherence and reduce drug spending

In vitro colonic fermentation of food ingredients isolated from Agave tequilana Weber var. azul applied on granola bars

The stem of Agave tequilana Weber is used to obtain fructans. Reports on the potential prebiotic activity of agave fructans as ingredients are scarce. The aim of this study was to evaluate the indigestible fraction (IF) content and the short chain fatty acid production (SCFA) from in vitro fermentation of: Native-agavefructans (NAF), agave-dietary-fiber (ADF), high-performance-fructans (HPF), both separately and as part of a composite granola bar. Agave ingredients and the IF of the agave granola bar were compared using an in vitro enzymatic digestion process followed by 24-h pH-controlled anaerobic batch cultures inoculated with human gut flora (fecal inoculum). Fermentation of agave ingredients resulted in a noticeable increase in SCFA production and the metabolite production profile varied with the fermentation time. Addition of NAF and ADF to granola modified the fermentation profiles, increasing propionate and butyrate molar ratios. Agave ingredients are good sources of fermentable dietary fiber with the ability to yield high concentrations of SCFA. (C) 2014 Elsevier Ltd. All rights reserved