Today, FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim). This is the second approved biosimilar to Neupogen approved in the U.S.
Nivestym is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:
• 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.
The most common expected side effects of Nivestym 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.
A biosimilar product is a biological product 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 be shown to have 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. For more information about biosimilar products, visit www.fda.gov/biosimilars.
For more information, please visit: Nivestym
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