Biosimilars

Two biosimilars for reference denosumab have received marketing authorization from the European Commission.

The FDA has approved trastuzumab-strf for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.

The FDA has approved an on-body injector (OBI) presentation of the biosimilar pegfilgrastim-cbqv biosimilar (Udencya), known as Udencya Onbody, which is administered to patients with cancer the day after chemotherapy in order to decrease infection incidence from febrile neutropenia.

EG12014, a biosimilar of the anti-HER2 monoclonal antibody trastuzumab, has received a marketing authorization from the European Commission for use in the European Union for the treatment of patients with HER2-positive breast and metastatic gastric cancer; these are the same indications that trastuzumab holds in the EU.

The biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of pegfilgrastim, has been resubmitted to the FDA for review.

The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.

The implementation of a pharmacist-driven biosimilar substitution program across American Oncology Network institutions resulted in increased uptake of biosimilar agents as well as financial savings for payers, patients, and providers.

The FDA has accepted a biologics license application for the HLX02, a proposed trastuzumab biosimilar, as adjuvant therapy for patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

The FDA has approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv (Udenyca), which is a biosimilar of pegfilgrastim that is given the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc.

With patents expiring on some of the revolutionary agents in cancer treatment, the emergence of biosimilars as a lower-cost option has seen exponential growth.

The FDA has approved bevacizumab-adcd, a bevacizumab biosimilar, for the treatment of six types of cancer.

The FDA has approved the biosimilar pegfilgrastim for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The European Commission has approved the bevacizumab biosimilar, CT-P16, for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.

Adjuvant treatment with TX05 resulted in a similar disease-free survival benefit to that of trastuzumab in patients with early-stage HER2-positive breast cancer.

The FDA has approved the biologics license application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta for the treatment of neutropenia.

The FDA has approved the third biosimilar for bevacizumab: bevacizumab-maly (Alymsys).

The addition of sintilimab to a bevacizumab biosimilar and pemetrexed/cisplatin resulted in a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after an EGFR TKI.

The combination of sintilimab, a bevacizumab biosimilar injection, and chemotherapy resulted in a significant improvement in progression-free survival in patients with EGFR-mutated, nonsquamous, non–small cell lung cancer that as progressed following treatment with an EGFR TKI, meeting the primary end point of the phase 3 ORIENT-31 trial.

Sanjiv S. Agarwala, MD, explains that biologics have revolutionized the treatment of serious conditions, including cancer, over the past few decades, however, costs are a pressing issue for all providers and biologics are a major culprit.

Understanding the functionality and naming convention of biosimilars vs their biologic counterparts are important concepts to utilizing these agents in oncology, according to a presentation given by Teresa Knoop, MSN, RN, AOCN, during the 5th Annual School of Nursing Oncology Meeting.

The use of oncology biosimilars has expanded rapidly in the United States during the past 2 years as providers embraced a growing armamentarium of new products, according to findings from real-world data reported at the 2021 American Society of Clinical Oncology Annual Meeting.

The rituximab biosimilar CT-P10 produced response and survival rates that were comparable to those previously reported with the reference product, along with acceptable tolerability, in patients with diffuse large B-cell lymphoma.

The FDA has accepted the biologics license application for a proposed biosimilar for pegfilgrastim, which had been developed by Lupin Limited.

Although the United States is behind Europe in terms of biosimilars approved and launched, the FDA is adding more approvals each year—29 since 2014—and 73 additional biosimilar candidates are in clinical trials and/or under FDA review.

Providers and health care institutions want more real-world data on how patients respond to various biosimilar products, according to a varied panel of private practice, academic hospital, and group purchasing organization experts in a discussion at the Community Oncology Alliance virtual 2021 Community Oncology Conference in April.

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.

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

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