FDA rejects Novartis’ application for Amgen’s Neulasta biosimilar

The FDA has rejected Novartis' copycat version of Amgen's blockbuster drug Neulasta.

The biosimilar, produced by the company's Sandoz unit, had sought a similar license as Amgen's original -- a long-acting granulocyte colony stimulating factor, used to increase the number of white cells in patients undergoing chemotherapy for cancers. Biosimilars are biopharmaceutical drugs designed to have active properties similar to one that had previously been licensed.

The drug, one of Amgen's top-selling products, nets around $5 billion in sales, with much of that revenue stream coming from the US.

However, for the first time, Novartis said in its second-quarter update that the FDA rejected its biosim application for the drug, which had been accepted by the regulator last November.

The review was expected to take 10 months.

Novartis said in its results, ''Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta). We are working with the agency to address remaining questions.'' The drugmaker did not offer further details.

The brief statement was tucked inside a press release announcing second-quarter results.

According to commentators, this would come as a blow to the company and possibly to other biosim manufacturers, just when it looked like the regulatory aspect was starting to look more predictable.

They point out that many issues this year had concerned companies trying to block each other with patent disputes but earlier month, both Novartis and Amgen had received nods from the FDA's advisory committees for their new, separate biosimilars. The final decisions are expected later this year.

According to Sandoz, its application was based on data from three Phase III trials, with one study focused on pharmacokinetics and pharmacodynamics in healthy volunteers, and two other studies assessing the drug's safety and efficacy in patients with breast cancer.

In March 2015, Sandoz, became the first pharma firm to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act, for Zarxio, (filgrastim-sndz) indicated in the treatment of neutropenia associated with chemotherapy.