Imagine this interesting and perhaps very real-life scenario. It could have several implications for the present biosimilar marketing picture. A reference manufacturer, we’ll call them Arby, signs multiple licensing deals with biosimilar manufacturers, to launch their products sequentially in 2025. The licensing deals all conclude outstanding patent litigation between the parties. But one biosimilar manufacturer … Continue reading The Potential Effect of Amgen’s Launch on Biosimilar Licensing Deals
Tag: at risk launch
Analyzing FDA Chief Gottlieb’s Remarks—Part 2: FDA and Marketing Exclusivity
Food and Drug Administration Chief Scott Gottlieb, MD, received a great deal of coverage for his recent remarks on providing better access to biosimilars. He seems intent on finding solutions to the underlying problems in delayed biosimilar launches. He discussed in the interview with CNBC perhaps the most intractable problem: The US biosimilar industry has … Continue reading Analyzing FDA Chief Gottlieb’s Remarks—Part 2: FDA and Marketing Exclusivity
Pfizer’s At-Risk Launch of Inflectra Pays Off (at Least a Bit)
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)