FDA Rejects Novartis' Biosimilar Application for Pegfilgrastim, Seeks Additional Information

Novartis and its generics unit, Sandoz, have been hailed as trailblazers in the biosimilar market in the United States, especially after the approval of Zarxio, biosimilar to Amgen. However, on an earnings call yesterday, Novartis announced that the FDA has sent a complete response letter for their product pegfilgrastim, biosimilar to Neulesta.

According to Reuters, Vasant Narasimhan, head of development at Novartis Pharmaceuticals said that the company had received the complete response letter in June. STAT News reported that Novartis told analysts on the call that the situation was complex and that they are working with the agency to address the remaining questions.

Novartis had filed the Biologics License Application (BLA) for pegfilgrastim late last year, about 8 months after Zarxio was approved by the FDA. A pegylated form of recombinant human granulocyte colony-stimulating factor, Amgen’s Neulesta is approved for use to reduce the incidence of infections in patients with non-myeloid malignancies who are receiving myelosuppressive anticancer agents. To seek approval for the same indications for it’s biosimilar, Sandoz submitted results from 2 pivotal clinical trials: a drug distribution trial in healthy volunteers and 2 comparative efficacy trials and safety studies in breast cancer patients.

Sandoz has been faring quite well on its other biosimilar products: it’s biosimilar to etanercept (Enbrel) was unanimously supported by an FDA advisory committee, and it’s biosimilar to rituximab (MabThera in the EU) was accepted for regulatory review by the European Medicines Agency.

Amgen, meanwhile, will have a breather for a short while. Neulasta earned $4.72 billion in sales last year, with a major chunk, $3.89 billion, from sales in the United States.