Evidence map›Paper›PMID 36251545›Full record

ReviewClinical pharmacology and therapeutics2023

Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary.

Sophie Shubow, Qin Sun, Ai Len Nguyen Phan, Dana C Hammell, Maureen Kane, Gary H Lyman, Allan Gibofsky, Gary R Lichtenstein, Zachary Bloomgarden, Raymond K Cross and 3 more

Open access · hybridAbstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
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

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  3. Article
  4. Individual Prescribing Incentives for Biosimilars in Selected European Countries and the USA: a Scoping Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Article
  5. Article
  6. Review
  7. Optimising oncology drug expenditure in Ireland.Irish journal of medical science · 2024
    Review
  8. Biosimilars in IBD: What Every Clinician Needs to Know.Current gastroenterology reports · 2024
    Review
  9. 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

13 authors at 7 institutions in 1 country.

Sophie ShubowOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Qin SunOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ai Len Nguyen PhanSchool of Pharmacy, University of Maryland, Baltimore, Maryland, USA.
Dana C HammellSchool of Pharmacy, University of Maryland, Baltimore, Maryland, USA.
Maureen KaneSchool of Pharmacy, University of Maryland, Baltimore, Maryland, USA.
Gary H LymanDepartment of Medicine, University of Washington, Seattle, Washington, USA.
Allan GibofskyDivision of Rheumatology, Weill Cornell College of Medicine, New York, New York, USA.
Gary R LichtensteinUniversity of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Zachary BloomgardenDivision of Endocrinology, Diabetes and Bone Disease, Department of Medicine, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA.
Raymond K CrossDivision of Gastroenterology and Hepatology, Department Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Sarah YimOffice of Therapeutic Biologics and Biosimilars, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA.
James E PolliSchool of Pharmacy, University of Maryland, Baltimore, Maryland, USA.ORCID 0000-0002-5274-4314
Yow-Ming WangOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-0663-7358
University of Maryland, Baltimore · USUnited States Food and Drug Administration · USCenter for Biologics Evaluation and Research · USCornell University · USMount Sinai Hospital · USUniversity of Pennsylvania · USUniversity of Washington · US

Funding

University of Maryland Center of Excellence in Regulatory Science and InnovationU01FD005946 · FDA · UNIV OF MARYLAND, COLLEGE PARK · PI BENTLEY, WILLIAM E., POLLI, JAMES E · 2016 to 2025
$21.5M
FDA HHS U01 FD005946
6 · The paper itself

Abstract

The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar approvals over the years, biosimilar adoption in the United States has been slow and gradual, largely driven by payers rather than clinicians. In order to better understand the barriers to biosimilar adoption in the clinic, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA jointly hosted a virtual workshop on April 13, 2022, titled "Biosimilars: A Decade of Experience and Future Directions - Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology." This summary documents the experiences of four leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology and their perspectives on how to increase biosimilar adoption, including the role of clinical pharmacology. Besides systemic changes in pricing and reimbursement, there is a need for additional education of a broad range of providers, including advanced care practitioners, and patients themselves. Educational efforts highlighting the rigor of the studies that support the approval of biosimilars-including the clinical pharmacology studies-and the benefits of biosimilars, can play a major role in improving biosimilar acceptance.

Indexed as

Biosimilar PharmaceuticalsPharmacology, ClinicalDrug ApprovalEducational StatusHealth Care CostsHumansUnited StatesUnited States Food and Drug AdministrationBiosimilar Pharmaceuticals

Identifiers

PMID36251545
PMCPMC10099086
OpenAlexW4306411883

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.