Mehta Analysis: Two Pillars of Industry Success Being Shaken
Regulators and policy makers are threatening the long-standing regulatory and patent protection structures that have helped prop the industry for many years. But pharma sustainability should in any case be based on innovation, writes Viren Mehta of Mehta Partners LLC.
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From Interchangeability To Exclusivity: US FDA Looks For Ways To Make Biologics Market More Competitive
The agency is being urged to help spur biosimilar development and market success by finalizing guidance on interchangeability, enhancing public education efforts, and taking a more forceful approach to combating misinformation, while reference product sponsors want FDA to adopt 'umbrella' exclusivity to encourage innovative changes in novel biologics.
As it enters a potentially golden decade, can biopharma seize the opportunity to overhaul its business model – and its reputation? Viren Mehta of Mehta Partners LLC discusses.