Approval of Sandoz’s Pegfilgrastim Biosimilar May Be Delayed until at Least 2018

As we previously reported, in July the FDA issued a complete response rejecting Sandoz’s aBLA for a biosimilar of Neulasta® (pegfilgrastim). Novartis, Sandoz’s parent, indicated that that Sandoz was “working with the agency to address remaining questions.” Earlier this week, on an earnings call for Q3 2016 with investors and analysts, Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis, revealed that Sandoz has “agreed with FDA to move forward with an additional study to address their data request and we would expect to submit that study to the FDA in 2018.”  Slide 42 of Novartis’s presentation slide deck (also available here) stated: “Plan to initiate additional study to address data request” with a “[p]otential data submission ~2018.”

The apparent delay of Sandoz’s approval until at least 2018 could open the door to its potential competitors in the pegfilgrastim biosimilar market, such as Apotex, whose aBLA was accepted by the FDA in December 2014 and who recently prevailed in the district court in its patent litigation against Amgen; or Coherus, whose aBLA was accepted just this month.

In addition, Novartis’s slide deck indicated on slide 43 that Sandoz is on track to file applications with the FDA for an epoetin alfa biosimilar and an adalimumab biosimilar later this year, and a rituximab biosimilar in 2017.

Also during the call, Novartis CEO Joseph Jimenez indicated that “Zarxio has had a good start and we have exceeded a $100 million since launch” in September 2015.

Stay tuned to Big Molecule Watch for further developments