Transferable Exclusivity Vouchers and Incentives for Antimicrobial Development in the European Union.

The European Commission's proposal to address antimicrobial resistance using transferable exclusivity vouchers (TEVs) is fundamentally flawed. European policymakers and regulators should consider alternatives, such as better funding for basic and clinical research, use of advance market commitments funded by a pay-or-play tax, or enacting an EU Fund for Antibiotic Development.

Broad Patent Claims Come Before the Supreme Court in Amgen v Sanofi.

This Viewpoint discusses a current Supreme Court lawsuit, Amgen v Sanofi, involving Amgen's broad patents on PCSK9 that could effectively prevent other manufacturers from producing similar or even clinically superior antibodies, with important negative consequences for patients.

Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings.

This cohort study assesses the frequency of approval and marketing of skinny-label biosimilars and their savings to Medicare.

Characteristics Of Key Patents Covering Recent FDA-Approved Drugs.

New drugs are protected by patents that block generic competition and allow manufacturers to charge high prices. To examine the breadth and characteristics of the key patents covering recently approved brand-name drugs, we extracted patents from the list maintained by the Food and Drug Administration (FDA) and evaluated the timing of patent filings, features of the drugs covered by patents, and whether similar patents were sought in other countries. Among seventy-eight qualifying drug approvals in 2019 and 2020, ten had zero patents, and the remaining sixty-eight drugs listed 322 different patents (the median number was 4). The most common category of patents, based on the nature of the invention being protected, was chemical compound (201; 62 percent), followed by method of use (195; 61 percent). The median time from originator drug approval to the expiration date of the final patent listed on our date of data collection was 10.3 years. About one in five patents had no counterparts in other major jurisdictions around the world, suggesting either a different manufacturer strategy or a differing application of patent standards in the US than in other comparable settings. Patents covering newly approved drugs largely protect the product and its uses; this shows that patent reform, rather than changes to nonpatent exclusivities, is the key to ensuring timely generic entry.

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

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.

Barriers To US Biosimilar Market Growth: Lessons From Biosimilar Patent Litigation.

High biologic drug prices have placed substantial strain on the US health care system. The Biologics Price Competition and Innovation Act (BPCIA), passed in 2010 as part of the Affordable Care Act, created an abbreviated approval pathway for biosimilars-versions of "originator" biologic drugs made by different manufacturers-to help address this issue. However, a decade after its passage, the BPCIA has spurred only limited competition. We examined the role that litigation has played in this muted success, reviewing all lawsuits related to the BPCIA filed between its enactment and August 1, 2020. Our review identified two key problems: noncompliance with steps in the complex litigation process established by the BPCIA and large numbers of patents enforced by originator manufacturers. Both actions have contributed to frequent confidential settlements between originator and biosimilar manufacturers that have delayed the availability of biosimilars. To facilitate more timely biosimilar entry, policy makers should consider limits on patent prosecution, compulsory public patent listing, and enhanced antitrust enforcement.

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.