On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s…
On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s…
There will soon be a new director of Therapeutic Biologics & Biosimilars Staff (TBBS) in the Office of New Drugs (OND) at the FDA. Dr. Sarah Yim will become the…
Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development. According…
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the…
Coherus Biosciences announced today that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners. According to the press release, the funds…
Here are our picks of some legal developments to keep an eye out for in the new year: Etanercept biosimilar trial decision – This past September, in the Immunex v….
Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market As a result of litigation and resulting…
Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018: 1. 2018 Sets New Records for Biosimilar Approvals and Launches When 2018 began, nine…
Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars. Bevacizumab: China-based Innovent Biologics announced last week that IBI305, a…
In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for…