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Novartis Seeks FDA Approval for Neupogen Biosimilar in US
Pharmaceutical giant Novartis has become the first company in the pharma industry to file an application with the FDA for approval of a biosimilar for marketing in the United States.
In what many regard as a portent of big, big things to come, Novartis is seeking approval to market their knockoff biological version of Amgen's Neupogen in the US. Neupogen (filgrastim) is a biological drug is given to cancer patients receiving chemotherapy known to compromise the bone marrow who are at risk for developing a potentially fatal complication known as febrile neutropenia.
Currently, Neupogen is costly, running anywhere from $3,000 to $4,000 or more per injection. The arrival of Novartis' biosimilar version could bring that cost down considerably.
The biosimilar version in question is already available in over 40 countries worldwide, where Novartis' generic arm Sandoz markets it under the brand name Zarzio. It is not the only knockoff of Neupogen available, but Zarzio is very likely the top-selling knockoff in the world.
"This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S., and we applaud FDA for its progress in making this a reality," said Sandoz's injectables chief, Dr. Mark McCamish, in a statement. "As they've done in Europe and other highly regulated markets around the world, biosimilars are poised to increase U.S. patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system."