Evidence map›Paper›PMID 40434488›Full record

ReviewCurrent rheumatology reports2025

Breaking Barriers: Essential Reforms for a Competitive and Affordable Biosimilars Market.

Eric T Roberts, Jinoos Yazdany

Abstract readReview
PubMed Publisher
In one paragraph

Review in Current rheumatology reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Eric T RobertsDivision of Rheumatology, Department of Medicine, University of California, San Francisco, USA. Eric.roberts@ucsf.edu.ORCID http://orcid.org/0009-0005-8435-8994
Jinoos YazdanyUniversity of California San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-3508-4094

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purpose of reviewThis update examines the current policy landscape for biosimilars, particularly those approved for treating rheumatoid arthritis. We review recent literature and recommend policies to align the biosimilars market with the goals of the Biologic Price Competition and Innovation Act (BPCIA). We examine updated evidence on biosimilar safety and effectiveness, recent FDA guidance on interchangeability, and challenges posed by anti-competitive behaviors and government regulations. Additionally, we analyze financial incentives and market dynamics affecting biosimilar adoption and competition. RECENT

findingsBuilding on the extensive body of RCT data demonstrating the safety and effectiveness of biosimilars, real-world evidence from North America and Europe now confirms these findings, including in patients who switched therapies. Increased biosimilar prescribing will depend on disseminating safety data and strategies to enhance patient-physician communication. The FDA updated its interchangeability guidance to no longer require large clinical studies, citing updated understanding of safety data; this may facilitate more direct price-based competition. Congress and the Federal Trade Commission need to address anticompetitive behaviors including patent law loopholes, the role of PBMs in inflating drug prices, vertical integration of healthcare conglomerates, and changes to funding for government agencies charged with reviewing biosimilar drugs. Medicare reimbursement rates and the 340B program still unfairly incentivize use of bio-originator products. There are many barriers to achieving the goals of the BPCIA. With necessary changes, the U.S. can realize the goal of a competitive and sustainable biosimilar market that gradually reduces total drug expenditures and out-of-pocket costs over time without stifling innovation.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsEconomic CompetitionDrug ApprovalHealth Care ReformHumansUnited StatesUnited States Food and Drug AdministrationAntirheumatic AgentsBiosimilar PharmaceuticalsBiologic Price Competition Innovation ActBiosimilar PolicyBiosimilar SafetyHealth Care PolicyMedicare ReimbursementPharmacy Benefit Managers

Identifiers

What OpenQuestion holds

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Registered trials

None linked

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.