Search Results: Uncategorized

Success for Pfizer’s Trastuzumab Biosimilar in Phase 3 Clinical Trials

Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat HER-positive metastatic breast cancer patients. Pfizer also reported success in a separate study, REFLECTIONS B3271004, evaluating this biosimilar in early…

Read More

Coherus Announces Marketing Authorization Application to the EMA for Pegfilgrastim Biosimilar

Coherus BioSciences, Inc., a global biosimilar company, is currently advancing three late-stage clinical products towards commercialization, namely CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar). In October, we reported that the FDA accepted Coherus’s aBLA for their pegfilgrastim biosimilar CHS-1701. Today, Coherus announced the acceptance of a Marketing…

Read More

District Court Stays Janssen’s Infliximab Lawsuit Against HyClone

On November 15, 2016, the U.S. District Court for the District of Utah entered a stipulated order to stay Janssen’s pending lawsuit against HyClone Laboratories, which supplies cell culture media for manufacturing Celltrion’s Inflectra® (infliximab-dyyb) biosimilar product.  Under the order, the Utah case will be stayed pending resolution of Janssen’s ongoing…

Read More

Regulatory News Roundup

The following are some noteworthy news stories on the regulatory front: The FDA shared best practices for biosimilar development. The EMA okayed a combination of insulin glargine and lixisenatide for treatment of type-2 diabetes. If approved, which is usually a formality within around 60 days, the EU will be the first…

Read More

Scheduling Order Entered in AbbVie v. Amgen

On Thursday, Judge Robinson entered a scheduling order in the AbbVie v. Amgen (adalimumab) case.  Among other things, the order sets a 20-day bench trial beginning November 4, 2019. The order also establishes a number of discovery and hearing deadlines that are somewhat different than those initially proposed before the…

Read More