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ODAC Rule on Anticancer Biosimilars Invigorates Discussion on Extrapolation


The month of July is turning out to be a very busy month for healthcare legislation. The Senate’s Better Care Reconciliation Act, which has not addressed the concerns around Medicaid re-expansion, per capita caps, and growth rates, lacks adequate Republican support. Additionally, a proposal from CMS to the Medicare outpatient proposed rule would dramatically reduce Medicare outpatient drug payments to 340B hospitals. On a positive note, on July 13, 2017, the FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilar versions of bevacizumab (Avastin) and trastuzumab (Herceptin). The committee did not consider bevacizumab's indications for ovarian cancer, since these indications are covered by orphan drug exclusivity until 2021 and 2023.

Bevacizumab is indicated for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non—small cell lung cancer (NSCLC), metastatic carcinoma of the colon or rectum, metastatic renal cell carcinoma, and other region-specific indications. Trastuzumab is indicated for the treatment of HER2-positive breast cancer, following surgery and for metastatic disease as well as for gastric cancer. The unanimous approval is a very positive ruling showing that there is a growing sense of acceptance and understanding of the biosimilars qualifications, compared with originator biologics.

This is huge news for US hospitals and clinics, since in 2016 both bevacizumab (Avastin) and trastuzumab (Herceptin) were 2 of the top 10 expenditures for both inpatient and outpatient stays. Infliximab (Remicade) was the top expenditure for 2016. Given that the United States is still new in the biosimilar market, the exact degree to which prices will drop remains unknown. However, since the United States spent over $5 billion on both bevacizumab (Avastin) and trastuzumab (Herceptin) in 2016, any price decrease has the potential to bring significant savings.

Perhaps the most interesting part of the ODAC hearing was discussion around the use of these anticancer agents and the support around extrapolating their use in a clinical setting. The FDA defines interchangeable products as biosimilar to an FDA-approved reference product, and can be expected to produce the same clinical result as the reference product in any given patient. An interchangeable product may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. However, if providers believe the therapeutic outcomes will be equivalent, even for indications for which there are no trials with the biosimilar, there may not be a need to pursue FDA interchangeability and hospitals can create their own policies.

Both the bevacizumab biosimilar, ABP 215, developed by Amgen, Inc, and the trastuzumab biosimilar, MYL-1401O, developed by Mylan GmbH, have a Biosimilar User Fee Act target action date of September 2017. With the FDA ruling against the 180-day marketing notices to the reference product manufacturer, these agents could be commercially available by the end of the year, if the manufacturing plants are ready. As more and more biosimilars enter the marketplace and there is more comfort with using them, we will hopefully see significant cost savings and improved patient access.

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