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Dr. Patel on Skepticism Associated With Biosimilars

Kashyap Patel, MD
Published: Monday, Oct 29, 2018



Kashyap Patel, MD, president, Carolina Blood and Cancer Center, medical director, International Oncology Network, discusses skepticism associated with biosimilars in oncology.

The manufacturing process of biologics has undergone a shift in how they have been developed over the last decade, explains Patel. For example, an originator biologic that was manufactured in 2004 is made differently in 2018. That drug is now a biosimilar of itself, Patel says. So, if no one questions that there is a batch-to-batch variation in biologics, Patel questions why oncologists would be skeptical of biosimilars.

In addition, the FDA has established an effective process called totality of evidence. This new standard looks at clinical efficacy, safety, and other factors of emerging biosimilars to prove their equivalence to biologics. Patel concludes that these measures should ensure the credibility of biosimilars. In December 2017, the FDA approved the trastuzumab (Herceptin) biosimilar MYL-1401O for the treatment of patients with HER2-positive breast cancer or metastatic gastric junction adenocarcinoma. There are other biosimilars being tested in clinical trials.


Kashyap Patel, MD, president, Carolina Blood and Cancer Center, medical director, International Oncology Network, discusses skepticism associated with biosimilars in oncology.

The manufacturing process of biologics has undergone a shift in how they have been developed over the last decade, explains Patel. For example, an originator biologic that was manufactured in 2004 is made differently in 2018. That drug is now a biosimilar of itself, Patel says. So, if no one questions that there is a batch-to-batch variation in biologics, Patel questions why oncologists would be skeptical of biosimilars.

In addition, the FDA has established an effective process called totality of evidence. This new standard looks at clinical efficacy, safety, and other factors of emerging biosimilars to prove their equivalence to biologics. Patel concludes that these measures should ensure the credibility of biosimilars. In December 2017, the FDA approved the trastuzumab (Herceptin) biosimilar MYL-1401O for the treatment of patients with HER2-positive breast cancer or metastatic gastric junction adenocarcinoma. There are other biosimilars being tested in clinical trials.



View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective OnlineNov 30, 20183.0
Community Practice Connections™: Evaluating the Emerging Role of Biosimilar Agents for the Treatment of Hematologic MalignanciesMar 08, 20193.0
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