FDA ODAC Recommends Biosimilar Bevacizumab and Trastuzumab

The reviewers found there were no clinically meaningful differences between the reference products and these two biosimilars

On 13 July 2017, the US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilar versions of bevacizumab (Avastin) and trastuzumab (Herceptin).

During the morning session, the ODAC members discussed biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s Avastin (bevacizumab), submitted by Amgen Inc. The committee members voted 17-0 in favour of approving Amgen's bevacizumab biosimilar candidate, ABP 215, for six of bevacizumab's indications. However, the committee did not consider whether Amgen's data would support approval for two of bevacizumab's indications for ovarian cancer, as they are covered by orphan drug exclusivity until 2021 and 2023. So, the indications/uses for this product are:

(1) For the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy;

(2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen;

(3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel;

(4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent;

(5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and

(6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

During the afternoon session, the ODAC members discussed biologics license application (BLA) 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.’s Herceptin (trastuzumab), submitted by Mylan GmbH. The ODAC members voted 16-0 in favour of approving Mylan's trastuzumab biosimilar candidate, MYL-1401O, for all of Herceptin's indications, including an indication for metastatic gastric cancer, which is protected by orphan drug exclusivity through 20 October, 2017. So, the indications/uses for this product are:

(1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multi-modality anthracycline based therapy;

(2) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer;

(3) as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and

(4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

The ODAC and FDA reviewers found there were no clinically meaningful differences between the reference products and these two biosimilars, though some panel members expressed concerns about extrapolating data from studies in a single disease to multiple indications.