In its recent earnings call discussing fourth-quarter 2019 results, Mylan disclosed that the US Food and Drug Administration (FDA) accepted its 351(k) application for a potential new bevacizumab biosimilar.
The application was submitted in the late fourth quarter of last year and was not publicized through Mylan’s communications department. The agent, MYL-1402O, had been subject to a phase 1 human trial, testing pharmacokinetic and pharmacodynamics similarity to the reference product with 111 healthy volunteers. A randomized study in patients with metastatic colorectal cancer was also conducted with an Indian patient population only, but it is unknown whether this study, which was used to secure approval in India, was included in the 351(k) submission. According to the company, the submission package included comprehensive analytical data, which in addition to the clinical study results, adequately demonstrated biosimilarity with Avastin®.
Another clinical study, testing the product in patients with stage 4 nonsquamous non–small cell lung cancer had been registered in 2016 in Europe, but there is no further information on whether this investigation was completed.
An FDA decision is expected on or before December 27, 2020. If approved, this agent could be the third or fourth bevacizumab available on the marketplace (depending on the status of Samsung Bioepis’ SB 8, which was filed for approval in November 2019).
In other biosimilar news…In the ongoing patent litigation between Sandoz and Amgen regarding Enbrel®, the case was heard in appeals court on March 4. Sandoz and its parent company Novartis have argued that the remaining patents on Enbrel are “obvious” and should be invalidated by the court, allowing a biosimilar to finally reach the market. In a report by FiercePharma, the majority of judges seem to be less than sympathetic to Sandoz, and this could extend Amgen’s market exclusivity through 2029— giving the reference drug an unprecedented 30 years of marketing protection. Sandoz’s biosimilar agent Erelzi® was approved by the FDA in 2016.