Biosimilars hold the potential to lower costs associated with stem cell transplant in oncology and haematology-related care
Haematopoietic cell transplantation (HCT) is an expensive modality and developing a transplant program is especially challenging in developing countries.
For oncology and haematology patients, including those requiring haematopoietic cell transplant (HCT), high medication-related expenses (related largely to antibiotics and growth factor-type biologics), are known to hinder access to healthcare worldwide. Patent expiration for biologics may result in biosimilars entering drugs markets and thereby helping to reduce the high costs associated with these therapies.
Biosimilars are chemically similar versions of reference biologic products with no clinically significant differences. Their regulatory approval is granted based on analytical validation studies and preclinical and clinical trials, usually involving a phase III randomised comparator study versus the originator biologic.
The Worldwide Network for Blood and Marrow Transplantation (WBMT) has reported that, despite having among the highest recent increases in HCT activity, only 2% of transplant teams operate in lower-income countries such as in the Eastern Mediterranean and African regions. Latin America has a 20–40-fold lower frequency of HCT compared with Europe and North America, and this limitation is probably due to limited funding. These findings underline an urgent need to implement effective strategies to cut costs for HCT in countries with restricted resources.
Biosimilars used in the field of HCT include granulocyte colony-stimulating factors (G-CSF) for stem cell mobilization, rituximab for graft-versus-host disease (GVHD), and, possibly, infliximab and etanercept in paediatric GVHD. In a meta-analysis of reported studies, most showed no significant difference in efficacy between biosimilar and originator biologic, and where cost analysis was included, reductions were noted for biosimilars.
Biosimilars have been shown to substantially reduce costs in developing countries. By 2024, the use of biosimilar G-CSFs and anti-neoplastics is predicted to result in a 10% cost reduction. The bulk of responsibility for raising awareness of biosimilars lies with governments, regulatory bodies, and local societies. Focusing on the benefits of biosimilars is an important aim for professional organisations specializing in HCT, especially for the education of practitioners in low-income countries.