Celltrion and Teva announce first Rituxan biosimilar approval in US
The US Food and Drug Administration (FDA) has approved Celltrion and Teva Pharmaceutical Industries’ Truxima (rituximab-abbs) for three non-Hodgkin’s lymphoma (NHL) indications.
Roche and Biogen’s rituximab – marketed as Rituxan by Genentech and Biogen Idec in the US, and as MabThera by Roche in the rest of the world, except Japan – is a therapeutic antibody that binds to the CD20-positive, non-Hodgkin’s lymphoma as a single agent.
Truxima (rituximab-abbs) is indicated for the treatment of adult patients with
- Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and
- Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.
Truxima is the product of a 2016 partnership agreement between Celltrion and Teva, aimed at developing, manufacturing and commercialising a rituximab biosimilar for the US and Canadian markets. The rituximab biosimilar is also the first to receive FDA approval since Rituxan entered the market in 1997.
Pricing and launch
The firms did not disclose the list price of Truxima, nor how it will compare to that of Rituxan – which brought Roche CHF 3.5bn ($3.5bn) in global sales in the first half of 2018. Pricing details will not be published until launch, a Teva spokesperson confirmed.
Teva and Celltrion have also been tight-lipped about a market entry date. A settlement agreement, including entry terms, has been reached with Genentech, according to Teva. “The terms and conditions of that agreement are confidential at this time.”
In Roche’s Q3 results last month, however, the Swiss manufacturer hinted that it expects a rituximab biosimilar to enter the US market in the first half of 2019.
“We are aware of competitive intelligence around, [and of] where people stand in terms of their approvals, and also when they may be able to launch,” CEO of Roche Pharmaceuticals, Dan O’Day, told investors in an earnings call.
“I think [Rituxan biosimilar launching first half of 2019] is our best estimate,” he added.
Regulatory hurdles
Celltrion and Teva’s regulatory path to approval has not been without challenges, with the receipt of an FDA warning letter, and a complete response letter (CRL) earlier this year.
The warning letter responded to an inspection of Celltrion’s South Korean manufacturing facility in May and June of last year, highlighting ‘multiple poor aseptic practices’. The FDA issued the CRL, rejecting the firms’ Truxima submission, in April this year.
Sandoz has also faced rituximab regulatory challenges in the US. Earlier this month, the firm announced it would not pursue its regulatory filing for Rituxan alternative, Rixathon, after the FDA requested additional information to complement its submission.
