Biosimilars

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.

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.

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.

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.

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.

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

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.

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.

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

The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab.

Ruth O’Regan, MD, shares her perspective on the use of biosimilars in breast cancer and their future in oncology.

Lee Schwartzberg, MD, FACP, advocates for the increased use of biosimilars in oncology and discusses the benefits of these agents for patients and providers.

Adam M. Brufsky, MD, PhD, FACP, discusses the emergence of biosimilars in oncology and how he anticipates they will change the paradigm.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Three biosimilars—bevacizumab-bvzr (Zirabev), rituximab-pvvr (Ruxience), and trastuzumab-qyyp)—will become available in the United States at a substantial discount to their reference products.

Ruth O’Regan, MD, and Adam M. Brufsky, MD, PhD, FACP, both discuss the emergence of trastuzumab biosimilars in breast cancer.

Francisco J. Esteva, MD, PhD, discusses the cost-saving potential of biosimilars in breast cancer and historical experience with their use.

Julie R. Gralow, MD, discusses the emergence of biosimilars in the United States and globally.

A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798.

Christopher A. Klebanoff, MD, discusses using biosimilars to reduce financial toxicity in breast cancer.

Megan Kruse, MD, discusses how to converse with patients with breast cancer about implementing biosimilars in treatment.

Julie R. Gralow, MD, discusses the science of biosimilars and their implementation in breast cancer.

Massimo Cristofanilli, MD, discusses the need for biosimilars in oncology.

John M. Pagel, MD, PhD, discusses the use of biosimilars in oncology and the importance of cost consciousness.

John Hays, MD, PhD, discusses the potential for PARP inhibitor combinations in patients with ovarian cancer.

Herbert A. Eradat, MD, discusses the implications of the FDA approval of rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan) in patients with CD20-positive B-cell Non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, discusses the potential utility of biosimilars in oncology.

Gregory Vidal, MD, PhD, discusses how the field will determine which trastuzumab (Herceptin) biosimilar to prescribe in clinical practice.