Biosimilars

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.

Biocon has announced that the FDA has issued a complete response letter for Mylan’s biologics License Application for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim (Neulasta).

The FDA approved the first biosimilar for the treatment of cancer. ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.

The FDA has accepted a biologics license application for the rituximab biosimilar Rixathon, according to Sandoz, the company developing the treatment.

The FDA has extended its decision deadline by 3 months on a biologics license application for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. A final decision is expected on or before December 3, 2017.

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to recommend approval to MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals.

The FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP-215, a biosimilar for bevacizumab (Avastin) to treat a range of solid tumors.

The FDA has rejected Hospira's a biologics license application for the epoetin alfa biosimilar, epoetin hospira, citing manufacturing concerns at the company's fill-finish facility in McPherson, Kansas.

The European Commission has approved the rituximab (Rituxan) biosimilar Rixathon (GP2013) to treat patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

The FDA’s Oncologic Drugs Committee voted 14-1 to recommend approving a biologics license application for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira.