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FDA Approves First Biosimilar Product, Zarxio (Filgrastim)
The FDA has given the nod to Zarxio (filgrastim-sndz, Sandoz), the first biosimilar product approved in the U.S.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms, or yeast.
A biosimilar product is a biological product that is approved based on evidence that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show that 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.
Zarxio is biosimilar to Neupogen (filgrastim, Amgen), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by health care professionals 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
- Patients with severe chronic neutropenia
The Biologics Price Competition and Innovation Act (BPCIA) of 2009 was passed as part of the Patient Protection and Affordable Care Act, which President Obama signed into law in March 2010. The BPCIA created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits the reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and allows a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.
A biosimilar product can be approved by the FDA only if it has the same mechanism of action, route of administration, and dosage forms and strengths as the reference product, and only for the indications and conditions of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.
The FDA’s approval of Zarxio was based on a review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data, all of which demonstrated that Zarxio is biosimilar to Neupogen. Zarxio has been approved as a biosimilar, not as an interchangeable product. Under the BPCIA, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
The most common expected adverse effects of Zarxio include aching in the bones or muscles and redness, swelling, or itching at the injection site. Serious adverse 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 (ARDS) –– a lung disease that can cause shortness of breath, difficulty breathing, and an increase in the rate of breathing.
For the new approval, the FDA designated “filgrastim-sndz” as the “placeholder” nonproprietary name for this product.
Source: FDA; March 6, 2015.