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Mundipharma International Ltd.. (12/20/16). "Press Release: CHMP Announces Positive Opinion for Biosimilar Rituximab Truxima and Mundipharma Has Secured Distribution Rights". Cambridge.

Region Region EU (European Union)
Organisations Organisation Mundipharma International Ltd.
  Group Purdue Pharma (Group)
  Organisation 2 Celltrion Healthcare Hungary Kft.
  Group Celltrion (Group)
Products Product Truxima® (biosimilar rituximab)
  Product 2 DRUGS, BIOGEN, GENERICS (biosimilars / biogenerics)
Index term Index term Purdue Pharma–Celltrion: rituximab, 201612– acquisition distribution rights for UK+IE+DE+IT+Benelux for biosimilar Truxima by Mundipharma
Person Person Mattessich, Antony (Purdue Pharma 201612 Managing Director of Mundipharma International Ltd)

• Truxima® (rituximab) is on track to become the first European-approved biosimilar monoclonal antibody for the treatment of cancer following a positive CHMP opinion1

• Mundipharma strengthens its biosimilar pipeline with the addition of Truxima® (rituximab) to its already existing biosimilar, infliximab

• The Mundipharma network of independent associated companies gains exclusive marketing and distribution rights for Truxima® (rituximab) in seven European countries including Germany, Italy and the UK

Mundipharma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Truxima® (rituximab) be granted marketing authorisation in the European Union for all the indications of the reference biologic.1 The CHMP’s opinion will now be reviewed by the European Commission (EC). If approved, Truxima® would be the first biosimilar rituximab to be approved by the EC.

Mundipharma also announced that it has secured a distribution licence from Celltrion Healthcare Hungary Kft for Truxima®. If approved, Mundipharma and its network of independent associated companies will have exclusive rights to market and distribute Truxima® in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands. Pending approval, Truxima® is set to be the second biosimilar monoclonal antibody to be marketed and distributed by the Mundipharma network, confirming them as leaders in marketing biosimilars in Europe.

“Mundipharma is establishing itself as a leader in biosimilars with our deep understanding of European markets and track record in delivering marketing excellence in a complex area,” said Antony Mattessich, Managing Director, Mundipharma International Limited. “Biosimilar rituximab has an enormous potential to deliver patient benefits while freeing up resources for novel cancer treatment options. That’s why biosimilars are becoming a key part of our business in Europe and we look forward to building on our partnership with Celltrion and continuing to identify further partnerships in this area.”

Truxima® is a medicinal product containing a monoclonal immunoglobulin G1 kappa antibody called rituximab. A biosimilar of reference biologic MabThera®, Truxima is expected to secure approval in all indications of the reference medicine – non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Truxima® has been tested in clinical and preclinical studies to demonstrate biosimilarity compared with reference rituximab.1 Clinical studies in people with both rheumatoid arthritis and advanced stage follicular lymphoma have demonstrated that Truxima® had a similar safety profile, immunogenicity and pharmacokinetics compared to reference rituximab.2-6 Similar efficacy to reference rituximab has also been demonstrated in published studies in rheumatoid arthritis.4-6

Truxima® will only be available in European markets after approval by the EC and any necessary patent clearances.


About Mundipharma

Mundipharma and its network of independent associated companies are privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of significant new treatment options in the core therapy areas of pain, respiratory, addiction, oncology and inflammatory conditions. Through innovation, design and acquisition, Mundipharma delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.

For further information please visit:

About Truxima®

Truxima® is a genetically engineered chimeric murine/human monoclonal immunoglobulin G1 kappa antibody currently being assessed by the EMA as a rituximab biosimilar. If granted marketing authorisation, the therapeutic indications as well as the dosing regimen for Truxima® will be the same as those of the reference rituximab product. Reference rituximab is currently indicated for non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.7

About biosimilars

Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical medicines that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which mean they contain an active drug substance that is comprised of, or derived from, a living organism. Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved reference product via a thorough development programme including quality, nonclinical and clinical data.

® TRUXIMA is a registered trade mark of Celltrion, Inc. and is used under licence.
® MABTHERA is a registered trade mark of F. Hoffmann-La Roche AG.

For further information please contact:

Mundipharma International Limited
Tel: +44 (0) 1223 397162
Lizzie Dowell

Tel: +44 207 067 0215


1. CHMP decision. Available online at: Last accessed December 2016.

2. B. Coiffier, et al. Pharmacokinetic and Safety of CTP10, a Biosimilar Candidate to the Rituximab Reference Product, in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma (AFL). 58th Annual Meeting and Exposition of the American Society of Hematology 2016; 1807.

3. Suh, CH. et al. Pharmacokinetics and Safety of Three Formulations of Rituximab (CTP10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks. American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting 2016; 1634.

4. Yoo, DH, et al. Efficacy and Safety of CTP10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks. American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting 2016; 1635.

5. Yoo, DH, et al. Efficacy and Safety of Switched CT-P10 from Innovator Rituximab Compared to Those of Maintained CT-P10 in Patients with Rheumatoid Arthritis up to 56 Weeks. American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting 2016; 1675.

6. Yoo, DH et al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis 2016;0:1–5

7. Mabthera Summary of Product Characteristics. Available online at: Last accessed December 2016

Record changed: 2019-04-26


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