Biosimilars

Citing the need for additional technical information, the FDA has issued a complete response letter to Pfizer regarding a biologics license application for the trastuzumab (Herceptin) biosimilar PF-05280014.

EP2006, a filgrastim biosimilar, produced safety results equivalent to those observed with referent filgrastim in a combined analysis of 2 phase III breast cancer studies from the United States and Europe.

Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses biosimilars in the oncology sphere.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of ABP 980, a biosimilar to trastuzumab.

Adam Brufsky, MD, PhD, comments the FDA approval of MYL-1401O and discusses the adoption of biosimilars in oncology.

Sunil Verma, MD, shares his insight on the approval of MYL-1401O, as well as his excitement for the future development of biosimilars across oncology.

Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discusses challenges facing biosimilars for the treatment of patients with breast cancer.

Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses incorporating biosimilars in oncology practice.

Hope Rugo, MD, professor of medicine, director of the Breast Oncology Clinical Trials Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses recent advancements with biosimilars.

The trastuzumab (Herceptin) biosimilar SB3 induced a rate of breast pathologic complete response similar to trastuzumab in women with HER2-positive breast cancer, according to results from a phase III study of 800 patients.

PF-05280586, a biosimilar for rituximab (Rituxan/MabThera), delivered positive top-line results in the phase III REFLECTIONS B3281006 follicular lymphoma trial.

The European Commission has approved the bevacizumab biosimilar ABP 215, for the treatment of patients across several tumor types.

The FDA has approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which now has has approved indications for HER2-positive patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of the bevacizumab biosimilar ABP 215 for the treatment of patients across several tumor types.