And then there was one. Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant®, an approved Herceptin® biosimilar. A Joint Stipulation of Dismissal is usually the confirmation that a licensing agreement has been reached. This leaves one remaining approved trastuzumab biosimilar maker that has not settled … Continue reading Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar
Tag: Udenyca
A Conversation With Doug Long, IQVIA
Doug Long, Vice President of Industry Relations at IQVIA (formerly QuintilesIMS), spoke with us about some of the intracacies of the filgrastim and pegfilgrastim marketplace, and regarding improving access to biosimilars in general. Doug Long, IQVIA BR&R: Do you think interest by manufacturers in biosimilars is gaining or waning at this time? Doug Long: It’s … Continue reading A Conversation With Doug Long, IQVIA
More Details on Coherus Bioscience’s Udenyca Launch
Go big or go home, seems to be the message of Coherus’ President Dennis Lanfear. At the JP Morgan Investor Conference yesterday in San Francisco, he outlined what he considers a “full-on branded launch” for the biosimilar maker’s key product. Udenyca was officially launched on January 3. In preparation for the launch of Udenyca, Coherus … Continue reading More Details on Coherus Bioscience’s Udenyca Launch
Udenyca to Launch January 3, Same WAC as Mylan’s Fulphila
Coherus Biosciences surprised many on its third-quarter earnings call late yesterday. It will rely not on a lower price than its biosimilar competitor to gain marketshare after Coherus' Udenyca launch, but on its ability to pull through on its patient and provider services and supply chain to gain significant marketshare for its biosimilar version of … Continue reading Udenyca to Launch January 3, Same WAC as Mylan’s Fulphila
Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar
With the Food and Drug Administration (FDA) approval today of Coherus Bioscience’s Udenyca™ (pegfilgrastim-cbqv), the second pegfilgrastim to compete with Amgen’s Neulasta®, much attention will be now focused on the company’s November 8 earning call. The FDA approved Udenyca on the basis of a supportive analytical similarity package, but with phase 1 data only. Over 600 … Continue reading Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar