When President Trump announced the broad strokes of his drug price reform initiative, some of these measures seemed on target to benefit the biosimilars industry. However long awaited, makers of originator biologics seemed not to be worried about its implications. The President may not be able to effect much change, without causing unintended adverse consequences. … Continue reading How Will Biosimilars Be Affected by Trump’s Drug Price Reform Measures?
Tag: patent expiration
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)
Lessons From a New Report: Do More Biosimilar Approvals Necessarily Mean Greater Access to Biologics?
Avalere Health issued a new report indicating that by 2025, 1.2 million US patients will be able to access biologic therapy because of biosimilar approvals. Why does biosimilar approval mean better access?