Biosimilars | Specialty

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.

US Biosimilar Portfolio Hits 10-Year Mark in Growth Mode

August 2nd 2020

Since the US regulatory and litigation pathway for biosimilars was signed into law in March 2010, the FDA has approved 28 biosimilar products, including 16 drugs with indications for patients with cancer.

Biosimilars Expand Patient Access to Novel Treatments

July 20th 2020

A panel of hematology-oncology experts discuss the emergence of biosimilar use in oncology.

Dr. Welslau on the Rationale for Rituximab Biosimilar Combination in DLBCL

June 29th 2020

Manfred Welslau, MD, discusses the rationale for investigating the Sandoz rituximab biosimilar, Rixathon, in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone in diffuse large B-cell lymphoma.

Bevacizumab Biosimilar Aybintio Receives Positive European Opinion

June 26th 2020

The Committee for Medicinal Products for Human Use has recommended approval of Aybintio, a bevacizumab (Avastin) biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union.

Dr. Ramakrishnan on the Promise of Biosimilars in Hematology

June 22nd 2020

Praveen Ramakrishnan, MD, discusses the promise of biosimilars in hematology.

FDA Approves Pfizer’s Pegfilgrastim Biosimilar

June 11th 2020

The FDA has approved pegfilgrastim-apgf, a biosimilar to pegfilgrastim, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Dr. Cuellar on the Pharmacoeconomic Benefits of Biosimilars

April 30th 2020

Sandra Cuellar, PharmD, BCOP, discusses the pharmacoeconomic benefits of biosimilars.

Trastuzumab Biosimilar Ontruzant Enters US Oncology Market

April 15th 2020

Trastuzumab-dttb (Ontruzant) is now officially available for clinical use in the United States.

The Future Direction of Biosimilars

March 16th 2020

The Availability of Multiple Biosimilars for 1 Biologic

March 16th 2020

Educating Physicians When Prescribing Biosimilars

March 16th 2020

Pharmacovigilance Requirements for Biosimilar Products

March 16th 2020

Biosimilar Interchangeability in Practice

March 16th 2020