Nichi-Iko Pharmaceuticals offered an update on its plans for its infliximab biosimilar, targeted for the US market. In its latest investor presentation, the company disclosed that it plans to file its 351(k) application in 2023, based on a phase 3 clinical trial, which was completed in 2020. It is in the process of preparing its Sagent Pharmaceuticals plant in the US for production. Nichi-Iko stated that this trial tested the interchangeability of its product (NI-071) versus the reference product Remicade®, yet the two phase 3 trials listed in ClinicalTrials.gov do not describe study designs with multiple switches.
Kevin Ali, Organon’s CEO, believes that big changes will be at hand when pharmacy benefit managers start taking a turn steering biosimilars’ course. Speaking on Tuesday at Fierce JP Morgan Week virtual conference, Mr. Ali stated that with adalimumab biosimilars getting to launch, he thinks “there is a big incentive for payers to convince patients to shift to biosimilars,” and that they may be better able to accomplish this through their PBMs. “I think that PBMs are more efficient and more aggressive [than the plans themselves].” Judging from the next Biosimilar Byte, some may question the PBM’s biosimilar approach.
An excellent analysis by Drug Channels of insulin products on the 2022 formularies of the three major pharmacy benefit managers (CVS Health, OptumRx, and Express Scripts) calls out the apparent irrationality of the market. The analysis focused on Semglee®, the biosimilar interchangeable with Lantus® (insulin glargine). CVS does not list Semglee or its related authorized biosimilar on formulary, favoring Basaglar® instead. Express Scripts prefers Semglee, but not the lower-priced authorized biosimilar, on its most commonly used formulary. OptumRx prefers Sanofi’s Lantus and excludes Semglee altogether. It sounds like rebate deals are being made all over the map.
Furthermore, Cigna made a splash last year when it offered $500 gift cards for patients to switch from Remicade to either the Inflectra® or Avasola® biosimilars. ESI is Cigna’s vertically integrated PBM, and Avasola is among ESI’s new formulary exclusions, Drug Channels pointed out.