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Pharmaceuticals
Special Issues
Biosimilars Development Strategies
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Biosimilars Development Strategies

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Medicinal Chemistry".

Deadline for manuscript submissions: 25 November 2025 | Viewed by 1308

Special Issue Editors

Dr. Sarfaraz K. Niazi

E-Mail Website
Guest Editor
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA
Interests: biosimilars; mRNA delivery; AI-driven protein structure; bioequivalence; pharmacokinetics
Special Issues, Collections and Topics in MDPI journals
Dr. Sesselja S. Ómarsdóttir

E-Mail Website
Guest Editor
Faculty of Pharmaceutical Sciences, University of Iceland, IS-107 Reykjavik, Iceland
Interests: biosimilars; biotechnology; natural products; medical devices; regulatory strategies

Special Issue Information

Dear Colleagues,

Biosimilars, also known as similar biological medicinal products or biosimilars, are biological products that are highly similar to an already approved biological medicine in terms of quality, safety, and efficacy. These products may exhibit minor differences with regard to their non-active components compared to the reference medicine, but show no substantial differences in terms of safety, purity, and potency. The development of biosimilars aims to reduce the cost of healthcare for patients and improve their access to biological therapies. The FDA defines a generic drug as one that is identical—or bioequivalent—to a branded drug in terms of its dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

This Special Issue focuses on the development of biosimilars, a rapidly evolving field with an immense potential to enhance patients’ access to affordable biological therapies. It explores aspects related to the design, manufacturing, and analytical characterization of biosimilars.

This Special Issue aims to provide a comprehensive overview of the latest advancements and challenges associated with the development of biosimilars. It will serve as a valuable resource for researchers and developers interested in this critical area of biopharmaceutical science.

Dr. Sarfaraz K. Niazi
Dr. Sesselja S. Ómarsdóttir
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • biosimilars
  • generic medicines
  • drug development
  • biosimilar development

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Published Papers (2 papers)

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18 pages, 3144 KiB  
Article
Comparative Forced Degradation Study of Anticomplement C5 Biosimilar and Originator Monoclonal Antibodies
by Merve Celik Yamaci, Ceren Pamukcu, Yigit Erdemgil, Ahmet Emin Atik, Zeynep Zulfiye Yildirim Keles and Ozge Can
Pharmaceuticals 2025, 18(4), 579; https://doi.org/10.3390/ph18040579 - 16 Apr 2025
Viewed by 524
Abstract
Background/Objectives: The stress testing of biotherapeutic products is a critical component of drug development, enabling the assessment of stability, biosimilarity, and degradation pathways. Subjecting biosimilar monoclonal antibodies to controlled stress conditions yields essential insights into their structural and functional integrity, informing formulation [...] Read more.
Background/Objectives: The stress testing of biotherapeutic products is a critical component of drug development, enabling the assessment of stability, biosimilarity, and degradation pathways. Subjecting biosimilar monoclonal antibodies to controlled stress conditions yields essential insights into their structural and functional integrity, informing formulation optimization and mitigating risks before clinical trials. In this study, biosimilar products were comprehensively characterized and compared with originator products under forced degradation. The aim was to expose the products to different stress conditions such as oxidative, pH, thermal, freeze/thaw, and agitation. The products were then tested at defined time points using validated analytical methods. Methods: This study employed size-exclusion chromatography to detect aggregated forms. Isoelectric focusing characterized protein charge variants (e.g., acidic/basic isoforms) from post-translational modifications, while capillary electrophoresis quantified product-related impurities (aggregates and fragments). In addition, a complement assay was used to determine the efficacy and potency under specific stress conditions. Results: Our findings showed that biosimilar and originator products exhibited similar degradation profiles. The biosimilar monoclonal antibody was found to be analytically similar to the originator product in terms of critical parameters related to efficacy and safety under various stress conditions such as aggregation profile, biological activity, and charge variant distribution. Conclusions: Forced degradation studies facilitated the comprehensive and well-validated characterization of the structure and biological activity of biosimilar monoclonal antibody products. Full article
(This article belongs to the Special Issue Biosimilars Development Strategies)
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Review

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15 pages, 236 KiB  
Review
Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies
by Sarfaraz K. Niazi
Pharmaceuticals 2025, 18(6), 779; https://doi.org/10.3390/ph18060779 - 23 May 2025
Viewed by 398
Abstract
This detailed review looks at how the rules for proving biosimilarity are changing, mainly focusing on the requirements for comparative efficacy studies (CESs). As analytical technologies progress, mounting evidence suggests that when we establish robust analytical similarity and pharmacokinetic equivalence, CESs become less [...] Read more.
This detailed review looks at how the rules for proving biosimilarity are changing, mainly focusing on the requirements for comparative efficacy studies (CESs). As analytical technologies progress, mounting evidence suggests that when we establish robust analytical similarity and pharmacokinetic equivalence, CESs become less valuable. This review combines findings from over 600 studies on biosimilars found in PubMed (showing that no biosimilar with proven analytical similarity has ever failed a CES), looks at the differences in global regulations on this topic, and explains how the Food and Drug Administration’s pharmacokinetic testing rules for biosimilars are similar to the bioequivalence testing for generics. Finally, specific changes to the Biologics Price Competition and Innovation Act (BPCIA) are suggested to make US rules match the growing global scientific agreement, which could lower development costs and speed up patient access to biosimilars while still keeping safety and effectiveness intact. Full article
(This article belongs to the Special Issue Biosimilars Development Strategies)
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