Recommended

Teva close to API business sale
Streamlined rAAV purification enables efficient upstream analytics – access now
First new IPF treatment in US for a decade
Webinar: Radiopharmaceuticals’ time-to-result challenge
AstraZeneca/Daiichi cancer drug boost
Takeda to move away from cell therapy
GSK appoints new CEO
news

Sandoz receives EU approval in Europe for Rixathon (biosimilar rituximab)

14
SHARES

The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine…

The European Commission (EC) has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera, which include blood cancers and immunological diseases

 

Reserve your FREE place

 


Address the time-to-result challenge posed by short shelf-life radiopharmaceuticals.

20 November 2025 | 3:00 PM GMT | FREE Virtual Panel Discussion

This webinar showcases the Growth Direct System; an RMM (Rapid Microbial Method) that improves on traditional membrane filtration, delivering increased accuracy, a faster time to result, enhanced data integrity compliance, and more control over the manufacturing process.

Key learning points:

  • Understand the benefits of full workflow microbiology quality control testing automation in radiopharmaceutical production
  • Learn about ITM’s implementation journey and considerations when evaluating the technology
  • Find out how the advanced optics and microcolony detection capabilities of Growth Direct® technology impact time to result (TTR).

Don’t miss your chance to learn from experts in the industry – Register for FREE

 

“Today’s approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics. It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies” said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz.

“Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years. We have worked with care and passion towards this approval, and now is the time when we are bringing this medicine to healthcare professional and patients in Europe.”

Indications

Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical – including pharmacokinetic/pharmacodynamic (PK/PD) – data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality.

Related topics

, , ,

Related organisations

,

Related drugs

Related people

Related diseases & conditions

Share via
Share via