Sandoz receives approval in Europe for biosimilar rituximab to treat blood cancers and immunological diseases

  • European Commission approves Sandoz  biosimilar rituximab to treat blood cancers and immunological diseases.
  • Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities.
  • Sandoz now has four biosimilars approved in Europe — more than any other company.1
19. 6. 2017

Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the European Commission (EC) has approved biosimilar rituximab* for use in Europe. Sandoz biosimilar rituximab is approved for use in all indications of the reference medicine, 2, 3. 

“Today’s approval of biosimilar rituximab 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 biosimilar rituximab 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.”

Biosimilar rituximab is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis2.

The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical — including pharmacokinetic/pharmacodynamic (PK/PD) — data. The program demonstrated biosimilar rituximab matches its reference medicine in terms of safety, efficacy, and quality4–7.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines. It is the pioneer and global leader in biosimilars, and now has four biosimilar medicines approved in Europe. Sandoz has a leading biosimilar pipeline, and plans to obtain approval for and launch four more biosimilars of major oncology and immunology biologics by 2020. A division of the Novartis Group, Sandoz is well positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing, and commercialization.

About biosimilar rituximab

EC approval was based on a comprehensive development program, including analytical, preclinical, and clinical data, demonstrating biosimilarity of biosimilar rituximab to the reference medicine.Clinical studies included:

  • The ASSIST-RA study, which demonstrated that biosimilar rituximab and its reference medicine have equivalent PK/PD profiles, with no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with rheumatoid arthritis6.
  • The ASSIST-FL study; a Phase III confirmatory efficacy and safety study. The study met its primary endpoint of equivalence in overall response rate (ORR) between biosimilar rituximab and the reference medicine after six months. Results also confirmed the comparable safety profile of the two medicines7. 

*Sandoz biosimilar rituximab has also been approved in the EU under a duplicate marketing authorization8.

European Economic Area (EEA). The European Economic Area (EEA) provides for the free movement of persons, goods, services and capital within the internal market of the European Union (EU) between its 28 member states, as well as three of the four member states of the European Free Trade Association (EFTA): Iceland, Liechtenstein, and Norway.

Registered trademark of F. Hoffmann-La Roche AG.


1. European Medicines Agency. European public assessment reports. Available at: [Accessed: June 2017].

2. European Medicines Agency. Summary of Product Characteristics.

3. European Medicines Agency. Summary of Product Characteristics. Available at: [Accessed: June 2017].

4. Visser J, et al. Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs. 2013; 27: 495–507. 

5. Da Silva A, et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014; 55: 1609–1617.

6. Smolen J, et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8–11 June 2016, London, UK: FRI0222.

7. Jurczak W, et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma. ASH annual meeting, 3–6 December 2016, San Diego, USA: 1809.

8. European Medicines Agency. Summary of Product Characteristics. 

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Lek, a Sandoz company, is one of the key pillars of the second-largest generic pharmaceutical company globally. Its role within Sandoz is to act as: a leading global development center for technologically demanding products and technologies; a key global manufacturing center for active pharmaceutical ingredients and medicines; a competence center for the development of vertically integrated products; a Sandoz competence center in the field of development and manufacturing of biosimilar active ingredients and products; a supply center for the markets of Central and Eastern Europe (CEE), South East Europe (SEE) and the Commonwealth of Independent States (CIS), and is responsible for marketing and sales of Sandoz products on the Slovenian market. For further information, please visit

Sandoz is a global leader in generic and biosimilar pharmaceuticals. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
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Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit

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This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.

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For additional information contact:
Katarina Klemenc
Corporate Communications 
Lek Pharmaceuticals d. d.
Phone: +386 1 580 22 43
Fax: +386 1 580 24 32