January 29th 2021
January 28, 2021 - The FDA has accepted a biologics license application for BAT1706, a proposed biosimilar to bevacizumab.
January 6th 2021
January 6, 2020 - The FDA has deferred action on the biologics license application for the proposed bevacizumab biosimilar MYL-1402O.
December 17th 2020
December 17, 2020 - The FDA has approved rituximab-arrx, a biosimilar to rituximab, for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
November 2nd 2020
In our exclusive interview, Gary H. Lyman, MD, MPH, discusses the current state of biosimilars in oncology, the pathways that have been established to ensure the safe delivery of these agents to patients, and the potential effects they could have on alleviating some of the current constraints within the health care system.
September 28th 2020
Frontline sintilimab injection in combination with bevacizumab biosimilar injection resulted in a statistically significant improvement in progression-free survival and overall survival compared with sorafenib in patients with advanced hepatocellular carcinoma.
August 25th 2020
Manfred Welslau, MD, discusses the interim results of the REFLECT trial in diffuse large B-cell lymphoma.
August 20th 2020
The European Commission has granted a marketing authorization to Aybintio, a bevacizumab biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union.
August 19th 2020
Sandra Cuellar, PharmD, BCOP, discusses challenges with data extrapolation for biosimilars.
August 7th 2020
Manfred Welslau, MD, discusses findings from the REFLECT interim analysis that reconfirmed the activity of the rituximab biosimilar SDZ-RTX, in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with diffuse large B-cell lymphoma.