skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration

Teva_Debuts_US_Rituximab

TEVA HAS LAUNCHED THE TRUXIMA RITUXIMAB BIOSIMILAR AT A 10% DISCOUNT TO RITUXAN Source: Shutterstock

 

Teva has launched the first biosimilar rival to Roche’s Rituxan (rituximab) in the US in the form of partner Celltrion’s Truxima (rituximab-abbs), stealing a march on competitor Pfizer, the only other firm to currently hold a US approval for biosimilar rituximab.

Noting that Truxima had been introduced at a 10% discount to the originator’s wholesale acquisition cost – with the biosimilar having a WAC of $845.55 for a 100mg vial and $4,227.75 for a 500mg vial – Teva highlighted that actual costs to patients and providers would be lower as the WAC did not account for additional rebates and discounts.

The biosimilar has been introduced under a settlement deal with the originator. Teva had not previously disclosed a launch date. The firm said Truxima was “now available in the US” but cited an official launch date of 11 November.

Pfizer’s Ruxience (rituximab-pvvr) version was approved by the US Food and Drug Administration earlier this year.  (Also see "FDA Approves Pfizer's Ruxience Rituximab Biosimilar" - Generics Bulletin, 24 Jul, 2019.) The company recently revealed plans to launch the Rituxan rival in January 2020 under its own settlement with Genentech, Roche and Biogen.  (Also see "Pfizer Lines Up Trio Of US Biosimilar Launches" - Generics Bulletin, 31 Oct, 2019.)

Meanwhile, Sandoz had announced late last year that it would no longer pursue biosimilar rituximab in the US after the FDA asked for more information on its version following a complete response letter. The CRL – issued in May 2018 – came despite the firm’s biosimilar rituximab already being approved in markets such as the EU, Japan and Australia.  (Also see "Sandoz drops rituximab after US seeks more data" - Generics Bulletin, 9 Nov, 2018.)

Celltrion is partnering with Teva for both its rituximab and trastuzumab biosimilars in the US and Canada, as part of a deal struck between the two firms in late 2016.

Boasts All NHL And CLL Indications; More To Follow
Truxima was initially approved by the FDA in late 2018 for three non-Hodgkin’s lymphoma indications.  (Also see "Celltrion’s Rituximab Biosimilar Is The First Greenlit By The FDA" - Generics Bulletin, 10 Dec, 2018.) Subsequently, the FDA in May this year approved Truxima for a fourth NHL indication as well as for treating chronic lymphocytic leukemia, meaning the biosimilar matched all of the reference product’s oncology indications for NHL and CLL.

“In light of a patent settlement with Genentech,” Teva noted, “Celltrion and Teva have a pending FDA submission for rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis, and a license from Genentech to expand the Truxima label to include these indications in Q2 2020.”

“We are excited about the first FDA-approved biosimilar to rituximab in the US,” said Teva’s vice-president and commercial head of North America, Brendan O’Grady. “Teva’s commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Teva’s mission of making accessible medications to help improve the lives of patients.”

Meanwhile, Celltrion Healthcare’s vice-chairman Hyoung-Ki Kim, said the firm was “pleased to announce the launch of the first rituximab biosimilar, Truxima, with our marketing partner Teva in the US.” He added that “the introduction of Truxima into the US market will contribute to addressing unmet needs of US patients as well.”

This article was updated on 8 November 2019 to clarify Teva's comments around Truxima's launch date.

Read also

  • Generics Bulletin

    Aurobindo Is Company Of The Year At GGB Awards

    By David Wallace

    Aurobindo has taken home the awards for Company of the Year and Acquisition of the Year at the Global Generics & Biosimilars Awards 2019, held in Frankfurt, Germany. Accord also received two awards, among a host of other recognized companies.

    Topics Biosimilars

  • Generics Bulletin

    Lupin Offloads Kyowa For $525m But Not Exiting Japan

    Lupin plans to invest in acquisitions and organic growth in the US and India after selling Japanese subsidiary Kyowa Pharma for an enterprise value of around $525m to Japan private equity group Unison Capital. But the Indian firm stresses it is not exiting Japan and will continue to look for marketing partnerships.

    Topics Deal trends Strategy

  • Generics Bulletin

    16th Annual CPhI Pharma Awards Winners Announced

    London – November 6th, 2019 – Yesterday evening, the Winners of the CPhI Pharma Awards powered by Informa Pharma Intelligence were announced during a gala celebration at The Forum, Congress Center Messe Frankfurt. Now in its sixteenth year, the CPhI Pharma Awards drew a crowd of leaders from across the pharma and biotech industries, to celebrate the thinkers and creators who are breaking new ground with their industry contributions. Each category at the prestigious Awards ceremony recognised innovation in the pharmaceutical industry, with the winners just as diverse as the categories themselves.  

;

Next steps

Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.

Our team is always happy to hear from you. Please call us at:

  • US Toll-Free  : +1 888 670 8900
  • US Toll           : +1 908 547 2200
  • UK & Europe : +44 (20) 337 73737
  • Australia        : +61 2 8705 6907
  • Japan              : +81 3 6273 4260

Or please submit your inquiry via the form so that we can provide you the best possible customer service.

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now: