The Japan Society for Hematopoietic Cell Transplantation (JSHCT)
Recombinant granulocyte colony-stimulating factor (G-CSF) has been widely used for patients with granulocytopenia since its launch in 1990s by three pharmaceutical companies. Its indication for the mobilization of hematopoietic stem cells in healthy donors was subsequently approved in April, 2000. JSHCT has been making effort to collect short and long-term adverse events associated with the use of G-CSF in healthy donors. The short and long-term safety data of related donors were collected from April 2000 to March 2010, and was presented in September 2010. The results showed that the constant occurrence of adverse events for which causal relationship with G-CSF could not be denied, but some of the events were predictable and could be avoided. It has also become clear that the incidence of hematologic malignancy in peripheral blood stem cell donors after the use of G-CSF was similar to that observed in bone marrow donors (the data were presented at 31st EBMT, 47th ASH, 33rd EBMT and 52nd ASH meetings). With these findings in related donors from those prospective investigational studies, G-CSF was approved for the use in unrelated donors, and unrelated allogeneic peripheral blood stem cell transplantation (PBSCT) became possible in Japan in September 2010. At the moment, three biosimilar G-CSF have been applying for license (one of them has already been approved in November 2012) and their indications include the use for the mobilization of stem cells in healthy donors even though clinical trials have not been conducted in healthy donors. JSHCT concludes it preferable that biosimilar G-CSFs need to adopt the same steps which original G-CSF adopted, and JSHCT makes our members thoroughly aware of following two things;
- Regarding the mobilization of allo-PBSCT in healthy donors, it should be started with related donors first and register them through the JSHCT pre-registry and follow-up system (Upon registry, we need to consider to establish the system which identifies the name of products used).
- The use for unrelated volunteer donors should be suspended until short and long-term safety of biosimilar G-CSF is confirmed.
Securing safety of HSCT donors, especially unrelated donors, is one of the main issues of "Act on Promoting Appropriate Offering of Hematopoietic Stem Cells for Transplantation." Therefore, JSHCT wishes the companies producing biosimilar G-CSF understand the meaning of two statements mentioned above. Our position statement is based on our research to secure safety for donors and at the same time matches international view. Therefore, our statement may be reconsidered on each occasion when particular changes in the international view occur in the future.