Biosimilars

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.

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.

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

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.

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

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.