FDA Sets Advisory Board Review Date for Cancer Biosimilars

On July 13, the Food and Drug Administration’s Oncology Drug Advisory Committee will meet for 2 sessions to review biosimilars that were submitted via the 351(k) pathway in November 2016 to challenge reference agents manufactured by Roche/Genentech.

That morning, the committee will review Amgen and Allergan’s 351(k) submission for its biosimilar version of bevacizumab (Avastin®), which is used for the treatment of patients with metastatic carcinoma of the colon or rectum; nonsquamous, non–small cell lung cancer; gliobastoma in adults; metastatic renal cell carcinoma; and cervical cancer. Avastin is also used off-label to treat several ocular disorders, including wet age-related macular degeneration.

In the afternoon, the same committee will ruminate on the evidence for recommending Mylan/Biocon’s biosimilar version of trastuzumab (Herceptin®) for approval. This agent’s proposed indications include HER2 overexpressing breast cancer (early treatment and metastatic) and metastatic gastric adenocarcinoma.

Final decisions on the approval of these agents are expected in the early third quarter of this year. Recommendations for approval by the Advisory Committee of either or both products would likely result in the launch of the first biosimilars for the direct treatment of cancer.

In other news…This week’s Digestive Disease Week scientific sessions yielded additional positive results in switching studies on Pfizer/Celltrion’s infliximab-dyyb (Inflectra® in the US). In the first, a phase 3 double-blind, controlled trial of 220 patients with Crohn’s disease from 16 countries, found no significant difference in efficacy and safety results compared with the originator product. The second investigation reported extended (2-year) results of Norway’s well-publicized phase 4 NOR-SWITCH study, which comprised 481 patients with inflammatory bowel disease.

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