The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.
The global biosimilars industry is continuing to prosper, with the FDA having granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar; Organon and Shanghai Henlius Biotech entering into a licensing agreement for 2 oncology biosimilar candidates; and Indonesian regulatory authorities approving a bevacizumab biosimilar.
FDA Approves New Indication for Riabni
Amgen shared that its rituximab biosimilar Riabni (rituximab-arrx) received a new indication for rheumatoid arthritis in combination with methotrexate.
Riabni is now available for use in adults with moderate to severe rheumatoid arthritis who have experienced a negative or inadequate response to 1 or more tumor necrosis factor antagonist therapies, such as adalimumab, etanercept, or infliximab.
Riabni was originally approved by the FDA in December 2020 for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. The biosimilar launched on the US market in January 2021.
“The approval of Riabni is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option,” said Murdo Gordon, the executive vice president of Global Commercial Operations at Amgen, in a statement.
Organon and Henlius Partner on Oncology Biosimilars
Organon and Shanghai Henlius Biotech announced a new partnership for the development and commercialization of 2 biosimilar candidates referencing Perjeta (pertuzumab) and Prolia/Xgeva (denosumab).
As part of the agreement, Organon will have the exclusive commercialization rights for HLX11 (pertuzumab biosimilar) and HLX14 (denosumab biosimilar) in all countries except China, including Hong Kong, Macau, and Taiwan.
Pertuzumab is indicated for treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who are being treated with trastuzumab and chemotherapy. HER2-positive breast cancer accounts for 20% of breast cancer cases in the United States.
Denosumab is used to treat patients with osteoporosis with a high risk of fracture, as well as for the prevention of skeletal-related events in patients with multiple myeloma or bone metastasis from solid tumors. Worldwide, osteoporosis affects more than 20% of women older than 50 years.
The agreement also allows for possible future negotiations on the license and global commercialization rights for an ipilimumab biosimilar candidate (HLX13) referencing Yervoy. Yervoy is used in the treatment of unresectable or metastatic melanoma, cutaneous melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non–small cell lung cancer (NSCLC), malignant pleural mesothelioma, and esophageal cancer.
Consideration for the partnership will include a $73-million up-front payment and additional milestone payments. Henlius will be in charge of development and will supply the products to Organon if they receive regulatory approval.
Innovent and Etana Receive Indonesian Biosimilar Approval
Innovent Biologics and Etana Biotechnologies Indonesia revealed that Bevagen, a bevacizumab biosimilar, was approved for marketing by the Indonesian Food and Drug Authority for the treatment of several types of cancer.
According to a company statement, Bevagen was approved for use in patients with certain types of colorectal cancer, breast cancer, NSCLC, and primary peritoneal cancer, as well as cancer of the ovaries, fallopian tubes, or cervix.
Etana will be responsible for commercialization of Bevagen in Indonesia as part of a licensing agreement with Innovent, the developer of the biosimilar. The 2 companies entered into the agreement in January 2021. In China, Bevagen is marketed under the name Byvasda and is commercialized by Innovent. Bevagen has the potential to be the first Chinese antibody drug to be marketed and locally produced in Southeast Asia.