BioDrugs

Lantsman, Taliya; Matulonis, Ursula A.

doi: 10.1007/s40259-025-00754-wpmid: 41703397

Antibody-drug conjugates (ADCs) have emerged as an efficacious and promising treatment for advanced gynecologic cancers. These agents are an innovative treatment strategy that combines a monoclonal antibody, a linker, and a cytotoxic payload. Currently, three ADCs have received Food and Drug Administration (FDA) approval for use in gynecologic malignancies: mirvetuximab soravtansine, tisotumab vedotin, and trastuzumab deruxtecan. The demonstrable efficacy of these therapeutic agents has catalyzed rapid advancements in the field, prompting investigations into novel antigen targets such as cadherin-6 and B7H4, varying payloads, and innovative construction designs in both preclinical and clinical settings. While enthusiasm for ADCs is substantial, their clinical utility is tempered by significant side effects, such as ocular toxicities and pneumonitis, that necessitate specialized management expertise. Furthermore, the inherent complexities of these drugs and their mechanisms of action underscore the need for further research into the relevance of biomarkers, methods of therapy resistance, and the potential for re-utilization of payloads and targets later in the disease course. This review focuses on the mechanisms of action of ADCs, their developmental trajectory, successes in gynecologic cancers, emerging areas of investigation, the prospective landscape, and current challenges in the field.

Bautista, Joshua Lawrence C.; Abellanosa, Elian Angelo M.; Jardiolin, Jaden G.; Calpo, Rizelle Anne A.; Noriega, Charles Nylxon C.; Devanadera, Mark Kevin P.; Lopez, Simon Miguel M.; Guevarra, Leonardo A.

doi: 10.1007/s40259-025-00764-8pmid: 41686334

Son, Se Hyeok; Woo, Seeone; Choi, Ayeon; Ahn, Seungwon; Yoo, Hee Chan

doi: 10.1007/s40259-026-00767-zpmid: 41733889

Engineered virus-like particles (eVLPs) have emerged as a promising class of delivery systems for genome editing agents. By combining the efficient cellular entry of viral vectors with the safety advantages of nonviral platforms, eVLPs enable transient delivery of ribonucleoproteins such as Cas9, base editors, and prime editors. Successive design strategies, from rational engineering to directed optimization, have progressively improved particle assembly, cargo stability, and editing efficiency. In parallel, pseudotyping approaches have expanded the versatility of eVLPs for cell-type-specific targeting. Recent preclinical studies highlight their potential across diverse applications, ranging from monogenic disease models to complex disorders, and support their advancement toward clinical translation. This review summarizes the structural and production principles of eVLPs, surveys key advances in their development, and discusses therapeutic opportunities and future challenges for their application in genome editing.

Kumar, Shania; Dalbeth, Nicola; Gasteiger, Chiara

doi: 10.1007/s40259-026-00765-1pmid: 41733888

BackgroundPatients with immune-mediated inflammatory diseases are routinely transitioned from originator biologics to biosimilars to reduce healthcare costs. While barriers related to patient and practitioner beliefs and knowledge are well-documented, less focus has been placed on system-level factors that may hinder biosimilar uptake.AimsThis review aims to identify system-level factors that impact biosimilar brand transitions for treatment of immune-mediated inflammatory diseases, as reported by key stakeholders involved in real-world brand changes.MethodsA scoping review was conducted following the Arksey and O'Malley framework and was reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for scoping reviews (PRISMA-ScR). A comprehensive search was performed in APA PsycInfo, Embase, PubMed, Scopus, and Web of Science, and databases for major conferences in rheumatology, dermatology, and gastroenterology. Data from relevant studies were extracted and summarized onto a structured coding sheet before being synthesized.ResultsOf 2301 articles screened, 47 journal articles and five conference abstracts were included. Most studies were conducted in the United States and focused primarily on rheumatology. Barriers and facilitators were organized into four overarching themes. These were regulatory and approval processes (e.g., tendering practices, interchangeability policies, prescriber guidelines), healthcare system policies and incentives (including quotas, insurance coverage, reimbursement mechanisms, and rebates), infrastructure and logistics (such as supply chain considerations and storage requirements), and communication and education (including media and expert influence and the involvement of patient organizations).ConclusionsMultiple components of the healthcare system play a role in successful biosimilar transitions. Leveraging regulations, policies, infrastructure, and communication before, during, and after transition offers a practical blueprint for managing brand changes across health systems and therapies.