Academic Journal
Beyond bioequivalence: a critical overview of the innovator AmBisome as the reference standard for liposomal amphotericin B generics.
| Τίτλος: | Beyond bioequivalence: a critical overview of the innovator AmBisome as the reference standard for liposomal amphotericin B generics. |
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| Συγγραφείς: | Bridi Cavassin F; Medical School, Faculdades Pequeno Príncipe (FPP), Curitiba, Brazil., Mihailenko Chaves Magri M; Department of Infectious Diseases and Tropical Medicine, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFAMUSP), São Paulo, Brazil. |
| Πηγή: | Expert opinion on drug delivery [Expert Opin Drug Deliv] 2026 Sep; Vol. 23 (9), pp. 1627-1638. Date of Electronic Publication: 2026 Jun 26. |
| Τύπος έκδοσης: | Journal Article; Review |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Informa Healthcare Country of Publication: England NLM ID: 101228421 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-7593 (Electronic) Linking ISSN: 17425247 NLM ISO Abbreviation: Expert Opin Drug Deliv Subsets: MEDLINE |
| Imprint Name(s): | Publication: London : Informa Healthcare Original Publication: London : Ashley Publications, Ltd. |
| Ιατρικοί όροι (MeSH): | Amphotericin B*/administration & dosage , Amphotericin B*/adverse effects , Amphotericin B*/pharmacokinetics , Antifungal Agents*/administration & dosage , Antifungal Agents*/adverse effects , Antifungal Agents*/pharmacokinetics, Drugs, Generic/administration & dosage ; Drugs, Generic/adverse effects ; Deoxycholic Acid/administration & dosage ; Deoxycholic Acid/adverse effects ; Therapeutic Equivalency ; Humans ; Reference Standards ; Drug Delivery Systems ; Animals ; Liposomes |
| Περίληψη: | Introduction: The advent of liposomal amphotericin B (L-AmB, commercialized as AmBisome) technology represented a paradigm shift in antifungal drug delivery, substantially reducing the severe, well-known nephrotoxicity historically associated with the conventional deoxycholate formulation (D-AmB). Despite this advance, the expiration of the innovator's patent has spurred the global development of generic liposomal preparations, raising critical biopharmaceutical and clinical safety concerns. Areas Covered: This article reviews the literature and regulatory landscape of L-AmB and its nanosimilars. A comprehensive search was performed using PubMed, Embase, and Web of Science (1990-2026), focusing on NBCDs, bioequivalence, and clinical safety. The scope includes an evaluation of marketed generic formulations, their regulatory registrations, and published comparative studies. We also discuss the clinical consequences of administering unstable generics during high-dose protocols. Expert Opinion: While recognizing the urgent need for affordable generic alternatives to democratize access in low- and middle-income countries (LMICs), we emphasize the necessity of stringent, internationally harmonized regulatory standards that go beyond conventional bioequivalence. Safeguarding biopharmaceutical fidelity is an indispensable clinical imperative to protect vulnerable patients from the severe hidden costs of therapeutic failure and drug-induced toxicity. |
| Contributed Indexing: | Keywords: Liposomal amphotericin B; bioequivalence; invasive fungal infections; nanosimilars; nephrotoxicity; non-biological complex drugs; regulatory standards; therapeutic equivalence |
| Substance Nomenclature: | 7XU7A7DROE (Amphotericin B) 0 (Antifungal Agents) 0 (Drugs, Generic) 0 (liposomal amphotericin B) 005990WHZZ (Deoxycholic Acid) 0 (Liposomes) |
| Entry Date(s): | Date Created: 20260626 Date Completed: 20260901 Latest Revision: 20260901 |
| Update Code: | 20260901 |
| DOI: | 10.1080/17425247.2026.2694580 |
| PMID: | 42359827 |
| Βάση Δεδομένων: | MEDLINE |
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