Kashyap Patel, MD, president of the Carolina Blood and Cancer Center and medical director of the International Oncology Network, discusses the importance of biosimilars in the oncology space.

Patel, an outspoken proponent of biosimilars, says he testified in October 2018 to the FDA’s Oncology Drugs Advisory Committee, in support of the currently approved biosimilars. Biosimilars are the rational solution to the seemingly unsustainable drug prices in oncology, he says. Although there are cost-effective strategies oncologists can implement into practice, biosimilars hold the strongest potential to solve the problem of rising drug prices.

However, there are challenges associated with biosimilars that still need to be addressed. Patel says that some insurance companies do not seem to fully understand their role in treatment, and even when biosimilars receive FDA approval, the US patent litigation system can delay the implementation of these drugs by up to 9 months.

Nonetheless, these agents are gradually entering the pipeline. In December 2017, the FDA approved the first trastuzumab (Herceptin) biosimilar, MYL-1401O (Ogivri, dkst-trastuzumab), for the treatment of patients with HER2-positive breast cancer or gastric adenocarcinoma. There are also approved biosimilars for bevacizumab (Avastin) and the supportive care agent filgrastrim (Neupogen).

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Kashyap Patel, MD, president of the Carolina Blood and Cancer Center and medical director of the International Oncology Network, discusses the importance of biosimilars in oncology.

Dr. Patel on the Importance of Biosimilars

Kashyap Patel, MD, president, Carolina Blood and Cancer Center, medical director, International Oncology Network, discusses cost-effective practices for oncologists.

Biosimilars are a rational solution for overcoming the rising issue of cost in oncology, but it is going to take some time before this class of drugs becomes part of routine clinical practice, Patel says. However, there are certain areas of practice that he refers to as “low-hanging fruit” that contribute to cost but can be addressed a lot more quickly.

First, providers can work towards reducing unnecessary hospitalization. Patients should be seen only when necessary, says Patel, and this is a financial component that has not been discussed.

The second area deals with providing appropriate end-of-life care. Currently, about 9% of patients who succumb to cancer do so in the hospital or intensive care unit—this is something that should not be happening, Patel notes. An additional factor is site of care delivery. For example, recently published studies show that the physician’s office is the most cost-effective place to deliver therapy.

With that being said, it is important to remember that high drug prices are the result of innovation, Patel says. Without innovation, oncologists will not find a cure for cancer.

Dr. Patel on Cost-Effective Strategies for Oncologists

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

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Dr. Patel on the Importance of Biosimilars

Dr. Patel on Cost-Effective Strategies for Oncologists

Dr. Patel on Skepticism Associated With Biosimilars