- Hopes of a U.S. approval for Novartis' copycat version of Rituxan, a Roche cancer medication, were knocked back Wednesday after the company's R&D division Sandoz received a complete response letter (CRL) to the Biologics Licensing Application for Rixathon.
- The FDA accepted the drug's application in September 2017. No reason behind the CRL has yet been disclosed, and Sandoz has given no indication of the timescale for refiling.
- In the U.S., Sandoz already has two biosimilars OK'd and, accounting for the Rixathon rejection, one other pending approval.
Rituxan (rituximab) has already faced biosimilar competition in Europe. Roche saw the initial impacts on its bottom line in the first nine months of 2017, as Celltrion's Truxima and Sandoz's Rixathon reached the market. Revenue from the cancer drug declined by 16% in the third quarter.
By pushing back the timeline for what could have been the first U.S. rituximab biosimilar, the FDA inadvertently gives Roche a moment to catch its breath. Steve Scala of Cowen & Co. suggested in an investor note that the big pharma doesn't expect competition from Rixathon until at least 2019. This follows Celltrion's CRL for its rituximab and trastuzumab biosimilars in April 2018.
"[Roche has] confirmed that provided the two biosimilar candidates cannot get FDA clearance this year, it wouldn't expect any other entrants in the US in 2018," Salim Syed of Mizuho Securities wrote in a note to investors.
The news is also a boost to Biogen, which had assumed a Rituxan biosimilar entry in its 2018 guidance. Biogen has co-exclusive commercialization rights for Rituxan in the U.S.
However, neither CRL is a total reprieve for Roche; Celltrion still expects approval for its filed rituximab biosimilar during 2018, according to Scala in an update, and Sandoz remains confident in its biosimilar pipeline.
According to a company statement, "Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible."
Roche's key defense against these biosimilars is boosting its market for newly-launched drugs, such as Tecentriq (atezolizumab) in cancer and Ocrevus (ocrelizumab) in multiple sclerosis.