DISQUS

mifare ladee · 2 years ago

This is the most ridiculous thing imaginable. Force a company with an identical product to market to perform tremendously expensive tests on humans for no productive purpose. Only the asshats in Washington DC could contemplate the twisted logic of that scenario.
Patrick O'Malley · 2 years ago

Maybe we should take big Pharma's patent portfolios away just to teach them a lesson. Spending on bringing drugs to market? Anybody involved knows that 90% of it is wasted scientific and bureaucratic excuses for R&D tax credits. The selfish pigs get us coming and going. They can keep their little purple pills anyway.
Mi-Notsofast Ladee · 2 years ago

The complex issues surrounding any biologic products is (a) determining if they really are identical, (b) evaluating the process that makes them to see if they are in fact safe. The technology to evaluate complex proteins for structural similarity isn't quite there yet. Even identical proteins however, can have drastically different effects if processed differently. This is not as cut and dry as small molecule compounds from Big Pharma. Instead, maybe more focus should be given to the FDA, it's funding process, and the regulatory hurdles necessary to approve new biologics. Double-blinded studies with massive patient numbers are simply too costly and too slow.