Evidence map›Paper›PMID 42572211›Full record

ArticleJournal of clinical pharmacology2026

FDA's Approval Summary of the First Biosimilar to Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease.

Poonam R Delvadia, Anantha Ram Nookala, Gopichand Gottipati, Sreedharan Sabarinath, Ramana S Uppoor, Mehul U Mehta, Xiulian Du, Yow-Ming C Wang, Milos Dokmanovic, Riley Myers and 8 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

18 authors.

Poonam R DelvadiaDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0006-0646-8087
Anantha Ram NookalaDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Gopichand GottipatiDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Sreedharan SabarinathDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0006-0392-4366
Ramana S UppoorDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Mehul U MehtaDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0003-4973-3822
Xiulian DuTherapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Yow-Ming C WangTherapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0002-0663-7358
Milos DokmanovicDivision of Product Quality Assessment XIII, Office of Product Quality Assessment III, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Riley MyersDivision of Product Quality Assessment XIII, Office of Product Quality Assessment III, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jessica StevensDivision of Neurology II, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Laura BaldassariDivision of Neurology II, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0003-1795-1542
Paul LeeDivision of Neurology II, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0002-6681-562X
Laura JawidzikDivision of Neurology II, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Sandhya ApparajuDivision of Gastroenterology, Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Suna SeoDivision of Gastroenterology, Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Nina N BrahmeScience Review Staff, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Sarah J SchrieberScience Review Staff, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development and approval of biosimilars are imperative for improving patient access to safe and effective treatments. This article summarizes the regulatory approval for Tyruko, the first FDA-approved biosimilar for natalizumab for the treatment of multiple sclerosis and Crohn's disease. Biosimilarity between the proposed biosimilar and the reference product was demonstrated through a comprehensive comparative assessment that included structural and functional characterization, pharmacokinetics (PK)/pharmacodynamics (PD) data, immunogenicity, and safety. The PD assessment incorporated a panel of biomarkers indicative of target engagement and downstream biological responses. The current case underscores the importance of the 351(k) pathway and highlights how the PD-based approach, in conjunction with comparative analytical assessments and PK data, supported the approval of the biosimilar through a study design relying on fewer subjects and a shorter duration compared to an efficacy study.

Indexed as

Biosimilar PharmaceuticalsCrohn DiseaseDrug ApprovalMultiple SclerosisNatalizumabHumansUnited StatesUnited States Food and Drug AdministrationBiosimilar PharmaceuticalsNatalizumabbiosimilarsmultiple sclerosisnatalizumabpharmacodynamic similaritypharmacokinetic similarity

Identifiers

PMID42572211
PMCPMC13454504

What OpenQuestion holds

Textmetadata
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.