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.

Measuring and Understanding Market Exclusivity Length for New Prescription Drugs in France, Australia, and the USA.

Background: Originator drug manufacturers use several strategies to delay generic competition in the USA, but it remains unclear whether this results in longer market exclusivity compared to other countries.

Objectives: We sought to understand how drug market exclusivity lengths vary between the USA and two comparable countries.

Methods: We focused on drugs approved within 2 years of each other in the USA, France, and Australia from 1995 to 2005, and we compared the lengths of exclusivity from marketing approval through first generic competition or June 2023 using Kaplan-Meier analyses.

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.

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.

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).

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).

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.

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.