1. DiGiulio, Sarah

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In September, the FDA approved bevacizumab-awwb as a biologic similar to bevacizumab for the treatment of patients with multiple types of cancer, including certain colorectal, lung, brain, kidney, and cervical cancers. It was the first biosimilar to be approved in the U.S. for patients with cancer after years of debate and discussion as to the place for such products in oncology.

Leah Christl, PhD. L... - Click to enlarge in new windowLeah Christl, PhD. Leah Christl, PhD

"The availability of these products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients," noted Leah Christl, PhD, Associate Director for Therapeutic Biologics in the Office of New Drugs at the FDA's Center for Drug Evaluation and Research.


FDA approval for a biosimilar differs from the agency's approval process for a conventional therapy. Approval for a biosimilar is based on whether or not that product can demonstrate biosimilarity to a reference product (not to independently establish the safety and effectiveness of the proposed product), Christl explained.


"The ability to rely on certain existing scientific knowledge about the reference product submitted by the biosimilar manufacturer to support the approval of the biosimilar product allows for a potentially shorter and less costly drug development program," Christl said. "This is what is meant by an 'abbreviated approval pathway'-and is one way to increase treatment options and improve access for the public at potentially lower cost."


The FDA uses a totality-of-the-evidence approach when reviewing a proposed biosimilar product for approval, she added. The approach considers all available data and information submitted by the sponsor, including analytical data, animal data, human pharmacokinetics and pharmacodynamics data, clinical immunogenicity, and clinical safety and effectiveness data. Demonstrating biosimilarity will be determined on a product-specific basis.


Legislation granting the FDA the authority to approve biosimilar products in the U.S. was enacted in 2010 as part of the Biologics Price Competition and Innovation Act (BPCI Act). However, biosimilars have been available in countries outside of the U.S., including in Europe, for years-sparking some questions about the role of these products in the U.S.


Here's what Christl told Oncology Times about some of those questions and the future of biosimilars in oncology.


1 Legislation from 2010 addressed getting biosimilars approved. Is 7 years a long time in terms of getting this product and/or other biosimilars approved?

"Since the passage of the BPCI Act, the FDA has worked very hard to implement the legislation by developing a framework and regulatory pathway for the review and approval of biosimilar and interchangeable products. This includes issuing guidances to help companies that develop these products understand the FDA's current thinking on many scientific and policy issues. The FDA also regularly engages with companies on product development questions through the Biosimilar Product Development program.


"The FDA has so far approved seven biosimilar products and many more are in the pipeline. The FDA undertakes a rigorous and thorough evaluation to ensure that a biosimilar product meets the agency's standard for approval."


2 What role do you see biosimilars playing in the treatment of cancer in the U.S. moving ahead?

"Many of today's most important medications are biological products, or biologics. These drugs, while expensive, have revolutionized how we treat many of today's most serious life-threatening and life-altering conditions and diseases. Biologics represent the cutting-edge of biomedical research and offer hope that treatment options for many serious medical conditions could soon be available.


"Introducing biosimilars into the U.S. will benefit patients who rely on biological products as part of their health care in a variety of ways. First, patients who currently need biologics, or who may need them in the future, will have access to a larger number of medicines. An increase in market competition may lead to significantly reduced costs for both patients and our health care system. Similar to the significant savings that we've seen through the introduction of generic drugs in the U.S., biosimilars have the potential to save our health systems billions of dollars over the coming years. It is an exciting time for biosimilar and interchangeable products-they are only going to grow."


3 What is most important for practicing oncologists and cancer care providers to know about biosimilars and the role they might play in cancer care?

"Biosimilars, once available on the market, have the potential to reduce costs for both patients and the overall health care system. This is true for cancer care and also for other conditions where biological products are used for treatments.


"It is important for health care providers to understand that the FDA undertakes a rigorous and thorough evaluation to ensure that a biosimilar product meets the agency's standard for approval. Health care providers and patients can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar when these products are used as intended. [And] once a biosimilar or interchangeable has been approved by the FDA, patients and health care providers will be able to rely upon the safety and effectiveness of an FDA-approved biosimilar just as they would for the reference product that the biosimilar was compared to.


"As with other drug products, health care professionals should review the prescribing information in the labeling for detailed information about the approved uses."