ArticleHealth affairs (Project Hope)2021
Barriers To US Biosimilar Market Growth: Lessons From Biosimilar Patent Litigation.
Article in Health affairs (Project Hope), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Facilitators and barriers to generic and biosimilar medications in the Middle East and North Africa: insights from physicians and pharmacists-a systematic review.European journal of clinical pharmacology · 2025Pooled it
- Out-of-Pocket Spending for Biologic Drugs After Biosimilar Competition for Medicare Patients.JAMA network open · 2026Article
- Biosimilars in the Era of Artificial Intelligence-International Regulations and the Use in Oncological Treatments.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Measuring and Understanding Market Exclusivity Length for New Prescription Drugs in France, Australia, and the USA.Pharmaceutical medicine · 2024Article
- Biologic patent challenges under the America Invents Act.Nature biotechnology · 2024Article
- Reduction of biologic pricing following biosimilar introduction: Analysis across 57 countries and regions, 2012-19.PloS one · 2024Article
- The prevalence of drug patent term extensions in the United States, 2000-2018.Nature biotechnology · 2023Article
- Biosimilars Adoption: Recognizing and Removing the RoadBlocks.ClinicoEconomics and outcomes research : CEOR · 2023Article
- Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland.JAMA network open · 2022Article
- The characteristics of patents impacting availability of biosimilars.Nature biotechnology · 2022Article
- Association of Generic Competition With Price Decreases in Physician-Administered Drugs and Estimated Price Decreases for Biosimilar Competition.JAMA network open · 2021Article
Corrections and comments
- Erratum issuedErrata.2021
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
34339242What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.