The Role of Biosimilars in Oncology - Episode 1
Kashyap Patel, MD: Biosimilars that are currently available in the oncology space—the first one approved was filgrastim; Sandoz was the first one that got approval. Then subsequently one of the products from Pfizer Inc was approved, Nivestym. Prior to that, though, there was a drug called Granix that was approved. Now there are about 3 more biosimilars approved in the therapeutic class as well. One is pegfilgrastim. That of course is supportive care, Udenyca. And then there’s a drug called Fulphila.
Then 2 more drugs approved in the therapy class, which are trastuzumab and the bevacizumab. Both of these drugs are in the regular therapy class approved just in last quarter. With the entry of so many biosimilars in the oncologic therapeutic market, we do expect to have a significant change the way physicians prescribe that. And when we’re looking into the value-based model going forward, these drugs are going to play a tremendous role in helping physicians, patients, providers, and payers.
The efficacy and potency of biosimilars are measured based on the totality of evidence. FDA created a separate path back in 2009 under the BPCIA [Biologics Price Competition and Innovation Act], to help incorporate safety, efficacy, and the lack of immunogenicity of the biosimilar. And the FDA created a path called the totality of the evidence evaluation, where multiple points are measured beginning from the structural similarity, to the analytical variance, to the chemical composition, as well as PK/PD [pharmacokinetic and pharmacodynamic], and immunogenicity. And if the compound with all the totality of factors is identified as very identical to the parent compound, the trial does not have to be done in the clinical space, simply because the FDA has understood the structural similarity as well as other aspects of chemicals. If they are more similar to parent compounds, then there will be no difference in efficacy as well.
For example, the drug called Udenyca was approved based on the totality of evidence, and trial in human volunteers but not in actual patients.