Dr. Patel on the Importance of Biosimilars

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).