Biosimilars | Specialty

Adoption of Biosimilars Varies by Practice Setting

March 29th 2021

The use of biosimilars to treat patients may differ across drug classes, according to a new study examining the relationship between biosimilar use and practice setting and patient/physician characteristics.

FDA Approval Sought for Bevacizumab Biosimilar BAT1706

January 29th 2021

January 28, 2021 - The FDA has accepted a biologics license application for BAT1706, a proposed biosimilar to bevacizumab.

FDA Defers Action on BLA for Bevacizumab Biosimilar MYL-1402O

January 6th 2021

January 6, 2020 - The FDA has deferred action on the biologics license application for the proposed bevacizumab biosimilar MYL-1402O.

FDA Approves Rituximab Biosimilar for NHL, CLL, GPA, and MPA

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.

Lyman on Bringing Biosimilars From Bench to Bedside in Oncology

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.

Injectable Sintilimab/Bevacizumab Biosimilar Combo Improves Survival in Frontline HCC

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.

Dr. Welslau on the Interim Results of the REFLECT Trial in DLBCL

August 25th 2020

Manfred Welslau, MD, discusses​ the interim results of the REFLECT trial in diffuse large B-cell lymphoma.

Bevacizumab Biosimilar Aybintio Approved in Europe

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.

Dr. Cuellar on Concerns With Extrapolating Data for Biosimilars

August 19th 2020

Sandra Cuellar, PharmD, BCOP, discusses challenges with ​data extrapolation for biosimilars. 

Interim REFLECT Analysis Reconfirms Efficacy, Safety of Rituximab Biosimilar in DLBCL

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.