ArticleNaunyn-Schmiedeberg's archives of pharmacology2025
Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information.
Article in Naunyn-Schmiedeberg's archives of pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Information on biosimilars was rarely disseminated on the Pharmaceuticals and Medical Devices Agency (PMDA) website of the Japanese Regulatory Agency until the fiscal year (FY) 2022. Therefore, the PMDA website for biosimilars was created in FY 2023. This study confirmed the PMDA website for biosimilars and surveyed information about the approval fiscal year, brand name, indications at the initial approval, type of biopharmaceuticals, and disease area at the initial approval based on review reports and the "List of Approved Products." The PMDA website for biosimilars provides information on the definition of biosimilar, approved biosimilar products, related guidelines and notifications, learning videos, presentation material, and publication articles. As of March 2024, 35 biosimilars were approved in Japan based on the following 18 active pharmaceutical ingredients: somatropin, epoetin-alfa, filgrastim, infliximab, insulin glargine, rituximab, etanercept, trastuzumab, agalsidase beta, bevacizumab, teriparatide, darbepoetin-alfa, insulin lispro, adalimumab, insulin aspart, ranibizumab, pegfilgrastim, and ustekinumab. The disease area comprised nine patterns: rheumatology, oncology, hematology, gastroenterology, dermatology, endocrinology, ophthalmology, bone, and inborn errors represented in numbers and percentages for each pattern: 12 (23.1%), 9 (17.3%), 8 (15.4%), 7 (13.5%), 7 (13.5%), 5 (9.6%), 2 (3.8%), 1 (1.9%), and 1 (1.9%), respectively. This website provides various information regarding biosimilars in Japan. It will be more important to effort the understanding and education for the healthcare providers and patients on biosimilar regulations. Moreover, information should be disseminated through the PMDA website of biosimilars to accelerate and ensure transparency regarding regulatory approvals and biosimilar regulations.
Indexed as
Identifiers
39951116What 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.