- Novartis Sandoz' unit has secured European approval for a biosimilar copy of Roche's Rituxan (rituximab), marking the growing threat to Roche's trio of top-selling drugs in the coming years.
- Rixathon, as the copycat version will be marketed, is Sandoz's fourth biosimilar licensed in Europe and is OK'd for use in all approved indications of Rituxan, which is also sold under the brand name Mabthera.
- Sandoz plans to submit another five biosimilars for approval in the U.S. and the EU by the end of the year, part of an aggressive push to file 11 of the copycat biologics over the three-year period ending in 2017. The generics unit expects the flurry of regulatory activity to result in five market launches by 2020.
Sales of Ritxuan/Mabthera, Avastin (bevacizumab) and Herceptin (trastuzumab) accounted for 53% of Roche's pharmaceuticals revenues last year. All three face looming competition from biosimilars, putting pressure on the Swiss giant to grow revenues from its newer drugs more quickly.
Roche has said it is confident it can find ways to boost growth through the the "biosimilar erosion curve." Even so, faster uptake of the copycat drugs — particularly if costs come down further with new entrants — could leave a hole in Roche's revenues.
Korean drugmaker Celltrion has begun selling a biosimilar of Rituxan following European approval in February, while copies of Herceptin and Avastin are being readied for regulatory review in the U.S.
Roche's sales for its Rituxan franchise grew by 3% in 2016, driven by increasing demand in China, the U.S. and Europe. Worldwide sales totaled 7.3 billion Swiss francs ($7.5 billion), with the U.S. market accounting for the majority.
On the other side of ledger, biosimilars could become big business for Sandoz. The generics subsidiary has already secured approvals in the U.S. for biosimilar copies to Amgen's Neupogen (filgrastim) and Enbrel (etanercept). Planned submissions for this year target AbbVie's blockbuster inflammatory drug Humira (adalimumab) and Amgen's Epogen (epoetin alfa).
The Rituxan copy will be submitted to the FDA later this year as well, threatening Roche in the U.S.
Litigation has tied up most the approved biosimilars in the U.S. to date, however, slowing the impact and delaying any potential savings for the system.