The agency will review the BLA for a monoclonal antibody biosimilar of Rituxan® (Genentech/Biogen) for the treatment of a host of diseases.
The global market for biosimilar monoclonal antibodies (mAbs) is growing at a compound annual growth rate of nearly 47% and will reach $4.1 billion by 2020, according to a 2016 report by Visiongain. This growth, according to the firm, is driven by the growth of the submarkets for rituximab and infliximab biosimilars.
Celltrion and Teva will likely be contributing further to the growth of the rituximab submarket beginning in 2018. The companies recently announced that the US FDA has agreed to review their Biologics License Application (BLA) for CT-P10, a rituximab biosimilar. The BLA covers the treatment of patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.
CT-P10, like rituximab, targets the B-cell surface protein CD20. B cells are involved in immune-related diseases such as rheumatoid arthritis, attacking healthy cells when they are overactive. They are also believed to play a role in hematological cancers such as NHL and CLL. The biosimilar is approved by the European Medicines Agency for the treatment of NHL, CLL, RA, granulomatosis with polyangiitis and microscopic polyangiitis.
As part of the exclusive partnership entered into by the two companies in 2016 to CT-P10 and CT-P6, a biosimilar to Herceptin (trastuzumab), in the U.S. and Canada, Celltrion has responsibility for completing the clinical development and regulatory filings for the two products, while Teva has responsibility for their commercialization in the two counties following regulatory approval. CT-P10 will be subject to standard review by FDA, with action expected early in 2018.
“As the global leader in biosimilars who brought Inflectra, the world’s first mAb biosimilar approved by the FDA, to the U.S., we are pleased and honored to have this opportunity to once again work with the FDA on CT-P10,” said Woo Sung Kee, Chief Executive Officer of Celltrion. “CT-P10, which has been approved in the EU, is continuing to build a solid track record since its launch there earlier this year and has provided patients with access to a high quality treatment option and has offered great savings in healthcare costs. I am hopeful that CT-P10 will bring similar benefits to the U.S. when approved.”
Added Rittman, Senior Vice President and General Manager, Teva Oncology: “Teva is pleased to announce this important milestone today, with our partner Celltrion, bringing us one step closer to making additional biosimilar treatment options available to patients in the U.S.”