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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.