Tbo-Filgrastim Gains a New Pediatric Indication and Vial Presentation

Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.
The Center for Biosimilars Staff
August 09, 2018
Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.

The FDA also approved a new presentation of the drug in 300 mcg/1 mL and 480 mcg/1.6 mL single-dose vials, though Teva will also continue to produce its previously approved prefilled syringe presentations. The new vial may give tbo-filgrastim an advantage over Sandoz’s biosimilar filgrastim, Zarxio, which is available in prefilled syringes that, according to the product’s label, are unable to accurately measure small volumes of the drug for pediatric use.

“The new pediatric indication and vial presentation of Granix expand the range of treatment options that can be of benefit to both patients and healthcare providers,” said Brendan O’Grady, executive vice president and head of North America commercial at Teva.

Click here to read more about tbo-filgrastim and neutropenia. 

In December 2017, at the American Society of Hematology 59th Annual Meeting and Exposition in Atlanta, Georgia, researchers presented findings from a phase 2 study of tbo-filgrastim in 50 pediatric patients, aged 1 month to 16 years, who were given a subcutaneous dose of 5 µg/kg of body weight once daily. The researchers found that a daily dose of tbo-filgrastim had a safety profile consistent with the safety profile in adult patients, and that no immunogenic response was observed in this population.

The lead researcher of the study, Noah Federman, MD, told The Center for Biosimilars® in an email that the findings had the potential to expand access to prophylaxis of neutropenia for children, as the reference, “while standard of care, is quite expensive, and there is a need for additional agents.”

Tbo-filgrastim was first approved in 2012, prior to the advent of the Biologics Price Competition and Innovation Act pathway for biosimilar approval. As such, the product is not a biosimilar from a regulatory standpoint, though it does compete in the United States with its reference and with Zarxio. Another biosimilar filgrastim, Pfizer’s Nivestym, is also approved—though not yet launched—in the United States.

The first follow-on filgrastim product to become available to US patients, tbo-filgrastim launched at a 15% discount to its reference, and within 17 months, gained a 34% share of the filgrastim market. After 34 months, that share grew to approximately 40%.
 

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