Today we will be discussing the biosimilar granulocyte -colony stimulating factor (or G-CSF ). G-CSF is currently used to treat and prevent neutropenia and to mobilize CD34+ peripheral blood stem cells from donors. “Biosimilars ” are generic, biological drugs that are not identical to the original.
Dr. Brian Smith , who wrote an editorial on the subject explains:
“Because they are produced in living cells, biosimilar proteins may differ from the parent drugs—post-translational events such as glycosylation, receptor kinetics, protein structure and even biological activity may be slightly different.”
Biosimilars have been used in other countries for close to ten years, and the savings are usually between 20-30%. As part of the Affordable Care Act of 2010, biosimilars may apply for FDA approval in the United States.
Dr. Bönig, who wrote a review on the subject, comments:
“Thus far, no biosimilars have been approved in the US. Novartis’ biosimilar G-CSF has received a positive vote from the advisory panel to the FDA, and a formal vote by the FDA is expected for March 2015.”
FDA approval, however, is based on similarity to the original product. A group of Italian researchers examined data on 29 pediatric hematology-oncology patients who received biosimilar G-CSF for peripheral blood stem cell mobilization and compared them to reference data from the original drug. The data showed no difference between the two drugs in healthy donors, and no major side effects from the biosimilar product.
Although the data for the biosimilar G-CSF is encouraging, Dr. Smith cautions:
“One caveat to this, however, is that data on use in one group that is of special interest to Blood Bank physicians – that is, normal hematopietic stem cell donors – is very sparse. For this reason a number of organizations, including the World Marrow Donor Association and the Executive Committee of the European Group for Blood and Marrow Transplantation discourage the use of biosimilar G-CSFs for mobilization of stem cells in healthy donors until more data on safety and efficacy is available.”
Now that the FDA may approve biosimilars in the United States, the savings could be significant. However, biosimilars require a higher degree of caution, especially with healthy donors, and doctors must be vigilant for long-term, adverse effects.
We’ll be back with another edition of Transfusion News on February 28. Thanks for joining us.
1. Abi Raad R, Smith B. Biosimilar Biologicals: Never identical but close enough. Transfusion 2014;55:229-231.
2. Bonig H, Becker PS, Schwebig A, Turner M. Biosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid? Transfusion 2014;55:430-439.
3. Cesaro S, Tridello G, Prete A, Dallorso S, Cannata E, Massaccesi E, Risso M, De Bortoli M, Caselli D. Biosimilar granulocyte-colony-stimulating factor for mobilization of autologous peripheral blood stem cells in pediatric hematology-oncology patients. Transfusion 2014;55:246-252.