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Agreements

Date: 2017-12-19

Type of information: Licensing agreement

Compound: Truxima® (CT-P10 - biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® )

Company: Celltrion Healthcare (South Korea) Hikma Pharmaceuticals (UK)

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Cancer - Oncology

Type agreement: licensing

Action mechanism:

  • biosimilar product/monoclonal antibody. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. It was developed by IDEC Pharmaceuticals (now Biogen) and Roche is in charge of global sales. Ritusimab patents already expired in Europe in December 2013 and will expire in the U.S. in September 2016.
  • Truxima™ is mAb biosimilar to Roche's MabThera® (rituximab), which is used to treat patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Disease: non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis

Details:

  • • On December 19, 2017, Hikma Pharmaceuticals announced that it has reached a licensing agreement with Celltrion and Celltrion Healthcare for Truxima™ (rituximab).  Truxima™ is the first biosimilar monoclonal antibody  in oncology to be granted European marketing authorisation. Hikma now has exclusive agreements with Celltrion for three biosimilar products - Truxima™ (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab) - in all its MENA markets.
  • Under the terms of the agreement, Hikma has the exclusive rights to distribute and market Truxima™ (rituximab) in all of its MENA markets, leveraging Hikma's strong local presence, biosimilar expertise, sales and marketing capabilities and regulatory expertise.
   

Financial terms:

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Is general: Yes