Adoption and Manufacturing of Biosimilars for Autoimmune Diseases in Jordan and the Middle East: Key Barriers, Opportunities, and Global Collaboration Models
| dc.contributor.author | Abu Sadaa, Mohammad | |
| dc.date.accessioned | 2025-12-22T12:17:07Z | |
| dc.date.available | 2025-12-22T12:17:07Z | |
| dc.date.issued | 2025 | |
| dc.description.abstract | Biologic medicines have transformed the treatment of autoimmune and chronic diseases, but their development is highly complex, time-consuming, and costly. Biosimilars, offering comparable safety and efficacy at lower cost, provide an important opportunity to expand patient access, particularly in low- and middle-income countries. This study examines the barriers and opportunities for biosimilar adoption and manufacturing in Jordan and the wider Middle East, with a focus on autoimmune diseases. A mixed-methods approach was applied, combining survey data from 87 pharmaceutical, healthcare, and regulatory professionals with seven expert interviews. Analysis centred on four domains: regulation, manufacturing, market readiness, and international collaboration, benchmarked against global models. Results indicate that although Jordan has had biosimilar guidelines aligned with EMA and WHO standards since 2015, practical implementation remains limited. Local firms are mainly engaged in final product operations and analytical testing, with no upstream capacity. Key challenges include high entry costs, a shortage of specialised expertise, limited physician confidence, pricing pressures, and low public awareness. The study concludes that Jordan’s biosimilar sector is still at an early stage. Progress requires phased development, beginning with stronger regulatory practice and fill-finish partnerships, and moving towards upstream capability through education, targeted training, and collaboration between academia, industry, and international suppliers. Such a framework could position Jordan as a credible regional contributor to biosimilar development. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/307 | |
| dc.title | Adoption and Manufacturing of Biosimilars for Autoimmune Diseases in Jordan and the Middle East: Key Barriers, Opportunities, and Global Collaboration Models | |
| dc.type | Thesis |