Calamia Matthias, Abraham Ivo
Medicines, National Health Care Institute, Amsterdam, The Netherlands.
Matrix45, Tucson, AZ, USA.
Expert Opin Biol Ther. 2023 Jul-Dec;23(8):653-657. doi: 10.1080/14712598.2023.2247972. Epub 2023 Aug 18.
Biologics have shown marked success over the past decades in disease areas as cancer, immunology and diabetes. However, elevated costs of innovative biologic medicines have led to an inequity in accessibility across the world. While 85% of the world's population lives in low- and middle- income countries (LMIC), 80% of the sales of monoclonal antibodies are attributed to Western countries, highlighting the pronounced market imbalance.
This perspective paper draws some analogies as well as differences between biosimilars and generics, aims to address the unmet need for treatment with biologics in LMICs by reviewing possible causes, economic and social, of low access, displaying the disparity between LMICs and HIC, and suggets countermeasures for this unmet medical need in LMICs.
It is up to all stakeholders to capitalize on the opportunity that biosimilars provide, mostly by committing to transparent collaboration, to make biotherapeutics accessible to all, regardless of region or country of residence.
在过去几十年中，生物制剂在癌症、免疫学和糖尿病等疾病领域已取得显著成功。然而，创新生物药物成本的不断攀升导致全球药品可及性出现不平等现象。虽然全球85%的人口生活在低收入和中等收入国家（LMIC），但单克隆抗体80%的销售额却来自西方国家，这凸显了明显的市场失衡。
本观点文章对生物类似药和仿制药进行了一些类比与区分，旨在通过审视导致LMIC地区生物制剂治疗可及性低的可能原因（包括经济和社会原因），展示LMIC与高收入国家（HIC）之间的差距，并针对LMIC地区这一未满足的医疗需求提出应对措施，以解决LMIC地区对生物制剂治疗的未满足需求。
所有利益相关者都应抓住生物类似药带来的机遇，主要通过致力于透明合作，使生物治疗药物无论在哪个地区或居住国，都能为所有人所用。
