Healthcare Amgen, Inc. (AMGN) Biosimilar Neulasta Receives CRL

Amgen, Inc. (AMGN) Biosimilar Neulasta Receives CRL

Published By News Desk at June 13, 2017 09:09 am The company noted that the CRLstems from the FDA's request for a reanalysis of a subset of subject samples from the 04 study with a modified, more sensitive immunogenicity assay

Coherus BioSciences (not covered) announced today that the company's application for CHS-1701,a biosimilar candidate to Amgen, Inc.'s (NASDAQ:AMGN) Neulasta (pegfilgrastim), has received a complete response letter (CRL) from the FDA. The BsUFA date for CHS-1701 was 6/9/17. The company noted that the CRLstems from the FDA's request for a reanalysis of a subset of subject samples from the 04 study with a modified, more sensitive immunogenicity assay. The agency did not request additional clinical data. Additionally, the FDA has requested additional manufacturing related information including data on control parameters and licensing details for manufacturing processes. No new process qualification lots will be required, and Coherus believes the manufacturing data request can be fulfilled with existing data. The company anticipates requiring a Type 1 meeting with the FDA, which typically takes 30 days to schedule. Coherus believes it can respond to the CRL within 6 months (including the time to schedule and conduct the Type 1 meeting),and that the FDA could take up to 6 months to evaluate the BLA resubmission. 

Based on Coherus mgt. commentary, CHS-1701 could receive an updated FDA decision by mid-2018. Following the Supreme Court's decision today (on 6/12/17) in the Amgen v. Sandoz case regarding Neupogen biosimilar Zarxio, which ruled that biosimilars manufacturers can provide their 180-day notice of commercial marketing to the developer of the originator molecule either before of after receiving FDA approval, Morgan Stanley anticipates that CHS-1701 could launch in mid-2018 shortly after approval if the resubmission is successful. As a reminder, Sandoz and Mylan are also developing biosimilar versions of Neulasta. Sandoz has previously received a CRL, and Novartis noted in its 1Q17 earnings call that it plans to resubmit its filing in early 2018. Mylan's BLA has been accepted by the FDA, with a BsUFA date set for 10/9/17; however, on its 1Q17 call Mylan indicated it didn't expect to launch until late 2018 or early 2019. If approved, the Sandoz and Mylan molecules could also theoretically launch in 2018. Therefore, while the firm did not has enough information on the Coherus molecule to gauge the resubmission's probability of success, Morgan Stanley sees it as likely that one of the three biosimilars in development could be approved and ready to launch in 2018. The firm previously modeled biosimilar Neulasta commercialization in early 2018, but have updated its model for a mid- 2018 launch. Morgan Stanley now projects biosimilar Neulasta obtaining ~1% total pegfilgrastim share in 2018E growing to ~5% and ~15% in 2019E and 2020E, respectively. The firm assumes most of the Onpro share (~50% rightnow) is sticky and only significantly penetrate the non-Onpro market.