Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front:
- Pfizer recently reported in a press release announcing financial results for Q4 2016 that in December 2016 its subsidiary Hospira resubmitted its aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha), in response to FDA’s 2015 complete response letter. This resubmission follows Pfizer’s report last summer that it was “working diligently to address the content of the letter.” In its recent press release, Pfizer stated that it “will continue to work closely with the agency on next steps and remains committed to bringing this important medicine to patients in the U.S. as quickly as possible.”
- In addition to providing information on the status of Sandoz’s adalimumab and pegfilgrastim biosimilar candidates, Novartis CEO Joseph Jimenez stated on Novartis’s January 25 earnings call for Q4 2016 that Sandoz was “on track” to file an aBLA for a rituximab biosimilar in 2017. The timing of the filing is due to FDA’s request “for additional progression free survival data from the Phase 3 studies,” and Sandoz needed “to wait for that data to mature in order to provide it for the filing.” According to Mr. Jimenez, “no other issues [are] behind the difference in timelines of different data requests from” the U.S. and from Europe, where Sandoz has already submitted an application.
- On AbbVie’s January 27 earnings call for Q4 2016, Chairman and CEO Richard Gonzalez reiterated AbbVie’s previously stated belief that its “portfolio of IP will protect HUMIRA within the U.S. until 2022.” This past fall, Amgen indicated that it was unlikely to launch its FDA-approved adalimumab biosimilar, Amjevita®, before 2018, given the pace of its ongoing patent litigation against AbbVie.