Sandoz Application for a Biosimilar of Amgen’s Neupogen Accepted by the FDA

More than four years after Congress allowed biosimilars, Sandoz said this month that the FDA had accepted its application for a biosimilar of Amgen’s Neupogen, a milestone in the race to develop the highly anticipated biological products.

The Swiss company’s move puts it in the lead to launch the first biosimilar product in the U.S. By law, the FDA has 10 months in which to review Sandoz’s application for Neupogen (filgrastim), which is prescribed to decrease infection in patients being treated with chemotherapy.

The FDA creation of a biosimilars pathway lags behind the European Medicines Agency (EMA), which has been regulating biosimilars since 2003.

Mark McCamish, global head of biopharmaceutical and oncology injectable development for Sandoz, says that compared with the EMA, the FDA has been more flexible with the clinical trial review, in some cases requiring less time spent evaluating patient data.

Sandoz already controls more than 50 percent of global market for biosimilars, and markets its version of filgrastim under the name Zarzio in more than 40 countries. In total, the drumaker markets three biosimilars outside the U.S. and has six more in late stage clinical trials. The company reported $420 million in total biosimilars sales last year, a 23 percent increase over the previous year.

But other companies are right behind. As of the end of May, the FDA had fielded 67 requests for an initial meeting to discuss development on 14 reference biologic products, according to the agency’s associate director for therapeutic biologics, Leah Christl. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.