Biosimilars

San Francisco, CA—An increasing number of biosimilars have been approved in the United States, but many clinicians are still poorly informed about what constitutes a biosimilar, and what is involved in their unique pathway to approval, said Andrew D. Zelenetz, MD, PhD, Medical Oncologist, Division of Hematologic Malignancies, Memorial Sloan Kettering Cancer Center, New York City. He discussed this topic at the NCCN 2019 Hematologic Malignancies meeting.

On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to Neulasta were approved in 2018.

Febrile neutropenia is a serious complication of cancer chemotherapy that can require treatment delays and chemotherapy dose reductions, which compromise the efficacy of treatment. Among patients with cancer who are receiving chemotherapy, approximately 1% have febrile neutropenia. This condition affects patient morbidity and mortality and its clinical management requires significant healthcare resources.

On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin.

On November 2, 2018, the FDA approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences), as the second biosimilar to pegfilgrastim (Neulasta), to reduce the risk for infection in patients with nonmyeloid malignancies who receive myelosuppressive chemotherapy, which may result in febrile neutropenia.

San Diego, CA—Filgrastim (Neupogen), a short-acting granulocyte colony-stimulating factor (G-CSF), has helped to manage chemotherapy-induced neutropenia in patients with nonmyeloid malignancies, but it comes with a hefty price tag. According to a recent study, biosimilars of filgrastim may provide a more affordable option for US payers, suggested Susan Gabriel, Director of Global Health Economics and Outcomes Research, Teva Pharmaceuticals, Frazer, PA, at the 2016 American Society of Hematology meeting.

The United States has the largest biologic drugs market and high prices for biologics, such as monoclonal antibodies, therapeutic proteins, immunomodulators, and growth factors. Cancer treatments utilize traditional chemical-based drugs and, increasingly, biologic-based drugs.

Copenhagen, Denmark—Biosimilar filgrastim (Nivestim; Hospira), which was approved earlier this year by the European Commission but not yet by the FDA, showed effectiveness for the treatment of neutropenia and febrile neutropenia (FN) in patients undergoing cytotoxic chemotherapy for solid tumors and hematologic malignancies, according to a study presented at the 2015 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology meeting.