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ABSTRACT
Introduction
The substantial acceleration in healthcare spending together with the expenditures to manage the COVID19 pandemic demand drug delivery solutions that enable a flexible care setting for high-dose monoclonal antibodies (mAbs) in oncology.
Areas covered
This expert opinion introduces an analogue-based framework applied to guide decision-making for associated product improvements for mAb medications that are either already authorized or in late-stage clinical development. The four pillars of this framework comprise (1) the drug delivery profile of current and emerging treatments in the market, (2) the needs and preferences of people treated with mAbs, (3) existing healthcare infrastructures, and (4) country-dependent reimbursement and procurement models. The following product optimization examples for mAb-based treatments are evaluated based on original research and review articles in the field: subcutaneous formulations, an established drug delivery modality to reduce parenteral dosing complexity, fixed-dose combinations, an emerging concept to complement combination therapy, and (connected) on-body delivery systems, an identified future opportunity to support dosing outside of a controlled healthcare institutional environment.
Expert opinion
Leveraging existing synergies and learnings from other disease areas is a measure to reduce associated development and commercialization costs and thus to provide sustainable product offerings already at the initial launch of a medication.
Article highlights
This expert opinion introduces an analogue-based decision framework that provided guidance in selecting the most appropriate drug delivery solution enabling dosing of high-dose monoclonal antibodies (mAbs) for the treatment of malignancies in a flexible care setting, including the option for home- and self-administration.
Possible synergies with other markets include (1) the drug delivery profile of current and emerging treatments in the target and reference markets, (2) the needs and preferences of people treated with mAbs, (3) existing healthcare infrastructures, and (4) country-dependent reimbursement and procurement models.
Selected case studies comprise subcutaneous formulations, as an established drug delivery modality to reduce parenteral dosing complexity, fixed-dose combinations, as an emerging concept to complement combination therapy, and (connected) on-body delivery systems, as an identified future opportunity to support a flexible care setting for mAb-based treatments.
Emerging technologies currently explored to further advance convenience with parenteral drug administration include high-concentration solutions to reduce the overall dosing volume and long-acting subcutaneous formulations to lower commonly observed infusion-related reactions via decreasing maximum serum mAb concentrations. Moreover, oral delivery technologies for biotherapeutics have been identified to possibly enable less invasive dosing of mAbs, but require further investigation in clinical trials. In particular, a broad implementation of the latter, provided it can be shown to deliver mAbs at reasonable dosing frequencies and costs, would represent a change in the dosing paradigm.
Implementing the respective drug delivery technologies with a platform approach will further support manufacturers in basing development and commercialization pathways on available knowledge for medications not only from within but also from outside the oncology market.
This box summarizes key points contained in the article.
Declaration of interest
B Bittner is an employee of F. Hoffmann-La Roche and owns stock in Roche. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
List of abbreviations
| Abbreviations | = | units |
| BRICS | = | Brazil, Russia, India, China and South Africa |
| Cmax | = | maximum serum concentration |
| EM7 | = | Emerging Markets Seven (China, India, Brazil, Russia, Mexico, Indonesia, and Turkey) |
| EMA | = | European Medicines Agency |
| EU | = | Europe/European; FDA Food and Drug Administration |
| FDC | = | fixed-dose combination |
| HPI | = | highlights of prescribing information |
| IBD | = | inflammatory bowel disease |
| IG | = | immunoglobulin |
| IVIG | = | intravenous immunoglobulin |
| mAb | = | monoclonal antibody |
| mg | = | milligram |
| MINT | = | Mexico, Indonesia, Nigeria, and Turkey |
| mL | = | milliliter |
| MS | = | multiple sclerosis |
| OECD | = | Economic Cooperation and Development |
| PD | = | pharmacodynamic |
| PK | = | pharmacokinetic |
| RA | = | rheumatoid arthritis |
| SCIG | = | subcutaneous immunoglobulin |
| SMPC | = | summary of product characteristics |
| US | = | United States |