Date: 2018-09-12
Type of information: Acceptation for review of a NDA
Product name: Truxima® (CT-P10)
Compound: biosimilar rituximab - biosimilar version of Mabthera®/Rituxan®
Therapeutic area: Autoimmune diseases - Cancer - Oncology
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. Rituximab patents already expired in Europe in December 2013 and in the U.S. in September 2016.
- Celltrion’s CT-P10, is a proposed biosimilar to Biogen and Genentech’s Rituxan®, Rituximab, the active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells.
- Celltrion and Teva entered into an exclusive partnership to commercialize CT-P6 and CT-P10 in the U.S. and Canada in October 2016 . As part of the agreement, Teva is responsible for all commercial activities in the U.S. and Canada , pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.
Company: Celltrion (Republic of Korea) Teva Pharmaceutical (Israel)
Disease:
- non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
Latest news:
- • On September 12, 2018, Celltrion announced that the FDA has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal antibody biosimilar to Rituxan® (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018.
- • On June 29, 2017, Celltrion and Teva Pharmaceutical Industries announced that the FDA has accepted for review the Biologics License Application (BLA) for CT-P10, a biosimilar to Rituxan® (rituximab), which is used to treat patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
- CT-P10 was approved by the European Commission in February 2017 and has been launched in the U.K. , Germany , Netherlands , Spain and the Republic of Korea . The BLA for CT-P10 has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected during the first quarter of 2018.
- • On April 27, 2017, Celltrion presented starting official sales of its second biosimilar, Truxima™, which was approved by the European Medicines Agency (EMA) in England. Since last April, Celltrion has provided Truxima™ to about 50 hospitals in England with its affiliate, Celltrion Healthcare, which is in charge of overseas marketing for the company products, and with Napp Pharmaceuticals, the distribution partner in England; also, at each hospital, hundreds of blood cancer and rheumatoid arthritis patients were confirmed to have completed their first Truxima™ administration. Among these patients, they included the patients switched to Truxima™ from originator infliximab.
- • On February 17, 2017, the European Commission has approved Truxima® for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
- • On December 15, 2016, a biosimilar medicine, Truxima® (rituximab), received a positive opinion from the CHMP for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
- • On November 12, 2015, Celltrion announced that it filed a request for European Medicines Agency (EMA) approval of CT-P10 on Nov. 10 (local time). CT-P10 is a candidate biosimilar of rituximab, which is used to treat hematological cancer, rheumatoid arthritis and transplant rejection. Celltrion has become the world’s first to submit its proposed rituximab-containing biosimilar. Celltrion is planning to proceed with the licensing procedure in Europe first and the legal confirmation procedure for the validity of collateral patents at the same time.
Patents:
Submission of marketing authorization application USA : 2017-06-29
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-02-17
Favourable opinion UE: 2016-12-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
