The US Court of Appeals handed Pfizer a big victory in its gamble to bring its biosimilar version of Remicade® to the market before the completion of patent litigation. On January 23, the Appeals Court ruled that Johnson & Johnson’s ‘471 patent in the case was declared invalid, clearing the way for sales of Inflectra® … Continue reading Pfizer’s At-Risk Launch of Inflectra Pays Off (at Least a Bit)
Tag: patent litigation
Fuzzy Patent Logic
Three other biosimilar manufacturers have already filed for approval in the US: Amgen/Allergan and Celltrion/Teva (separately) in July 2017; Mylan/Biocon in November 2016. Roche settled its patent claims against Mylan in March 2017, which provides Mylan with a license to sell its biosimilar version of Herceptin® should it gain FDA approval next year.
News in the Courts on Biosimilars
According to a Reuters report, Janssen Biotech withdrew its patent lawsuit against Samsung Bioepis on November 10. The suit alleged infringement in the manufacture of Samsung’s infliximab biosimilar. The action, which was filed in U.S. District Court of New Jersey, means that Merck and Samsung, which launched Renflexis™ in July, is no longer at risk … Continue reading News in the Courts on Biosimilars
Amgen/Allergan Score Positive EMA Evaluation, but Launch Will Be Delayed
The European Medicines Agency s drug evaluation arm, the Committee for Medicinal Products for Human Use, recommended approval of the biosimilar bevacizumab on November 9.
Can Biosimilars Be Protected By Patent?
“Are biosimilars patentable?” Sounds like a simple question, right? Well, the answer may not be straightforward, and relate to another question: "Exactly how different are they?"