Evidence map›Paper›PMID 42675372›Full record

ArticlePharmaceutical research2026

Generic Long-Acting Injectable Product Availability and Approval Standards.

Krista Anim Anno, Doortje Esther Lubberts, Lei Zhang, Sarah Ibrahim, Jessica T Smith, Kevin Blake, Arno Nolting, Carolien Versantvoort, Wenlei Jiang

Abstract read
PubMed Publisher
In one paragraph

Article in Pharmaceutical research, 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

9 authors.

Krista Anim AnnoOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0001-7249-8344
Doortje Esther LubbertsDepartment of Anaesthesiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.ORCID http://orcid.org/0009-0005-5871-1950
Lei ZhangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0002-0639-3162
Sarah IbrahimImmediate Office, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0009-0003-8264-2452
Jessica T SmithImmediate Office, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0001-7884-923X
Kevin BlakeEuropean Medicines Agency, 1083 HS, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0001-7165-4579
Arno NoltingSwissmedic, Schweizerisches Heilmittelinstitut, Hallerstrasse 7, Bern, 3012, Switzerland.ORCID http://orcid.org/0009-0000-3590-0584
Carolien VersantvoortDepartment of Pharmacology, Toxicology and Kinetics, Medicines Evaluation Board, Utrecht, The Netherlands.ORCID http://orcid.org/0009-0001-6030-4271
Wenlei JiangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA. Wenlei.Jiang@fda.hhs.gov.ORCID http://orcid.org/0009-0009-3876-638X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLong-acting injectables (LAIs) offer substantial clinical and economic advantages, including improved patient adherence, enhanced safety and efficacy, and reduced overall healthcare costs. Despite these benefits, the availability of generic LAIs remains limited, largely due to the complexity of formulation development and regulatory assessment. This study aimed to characterize the landscape of LAI product availability, regulatory frameworks, and approval standards in the United States and Europe, and to identify opportunities to support generic LAI development.

methodsA comparative analysis was conducted of LAI product approvals through December 2025, along with regulatory guidance documents issued by the U.S. Food and Drug Administration (FDA) through February 2026, the European Medicines Agency (EMA) through December 2025, and European national agencies through July 2023.

resultsThe FDA approved 64 distinct new LAIs via the 505(b)(1) and 505(b)(2) pathways and 13 generic LAIs via the 505(j) pathway. In contrast, new and generic LAIs covering 26 and 15 active pharmaceutical ingredients (API), respectively, were approved by the EMA and European national agencies. The FDA issued 48 product-specific guidances (PSGs) for LAIs, whereas the EMA published five PSGs in addition to general modified-release guidance documents. Both agencies issued PSGs for five shared LAI products: exenatide, lanreotide, octreotide, and paliperidone palmitate (1-month and 3-month formulations). Comparative review of these PSGs revealed both alignment and differences in bioequivalence recommendations. Global collaborative efforts to promote generic LAI development were highlighted.

conclusionsThese findings provide a foundation for harmonizing generic LAI approval standards, which may improve resource allocation, promote generic competition, and enhance patient access to LAI therapies.

Indexed as

complex generic productscontrolled releasegenericslong-acting injectable

Identifiers

PMID42675372

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.