In a stealthy move, Novartis released negative news within the bowels of a July 19th earnings report. Its subsidiary, Sandoz, received a complete response letter from the Food and Drug Administration (FDA) regarding its pegfilgrastim biosimilar application. A complete response letter is FDA’s euphemism for a formal rejection.
Sandoz is seeking to introduce its pegfilgrastim biosimilar as a competitor to Neulasta®, Amgen’s innovator product, which is indicated to prevent the development of infection in patients receiving cancer chemotherapy.
Novartis provided the news, buried as the last bullet under a section titled “Results from important clinical trials and other highlights.” The bullet reads, “Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta®). We are working with the agency to address remaining questions.” A complete response letter means that based on the current data available, the agency has decided not to approve the drug for marketing.
Ed Silverman, an industry journalist, believes that Sandoz was issued the complete response letter in June. Unlike what you might think, FDA complete response letters are not released by the agency.
Sandoz first submitted its 351(k) filing on November 18, 2015 (https://biosimilarsrr.com/us-biosimilar-filings/). Ordinarily, an FDA Advisory Committee meeting would be scheduled to evaluate the product, but this did not happen. With other new drug filings, it sometimes means that FDA believes the original filing is missing data or clinical study information before it is ready to move forward.