|Brand name(s), other common name(s)||ZarxioTM|
|Drug type||Biosimilar growth factor|
|How the drug is given||Subcutaneous (SC) injection or intravenously (IV)|
Indications and Usage
Filgrastim-sndz is FDA approved as a biosimilar to US-licensed Neupogen® for the five indications for which Neupogen is approved:
- Patients with cancer receiving myelosuppressive chemotherapy;
- Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
- Patients with cancer undergoing bone marrow transplantation;
- Patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
- Patients with severe chronic neutropenia.
Side effects needing medical attention
The most common side effects are: aching in the bones or muscles and redness, swelling or itching at injection site.
Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.
What is a Biosimilar?
A biosimilar product is a biological product (generally derived from a living organism) that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA?s standards.