Attempts to bring generics of Novartis’ Gilenya (fingolimod) blockbuster to the US market eight years ahead of schedule have failed for now, with the US Patent Trial and Appeal (PTAB) ruling that a dosing patent shielding the multiple sclerosis drug should stand, rejecting challenges from Apotex, Argentum, Sun Pharma and Teva.
Attempts to bring generics of Novartis’ Gilenya (fingolimod) blockbuster to the US market eight years ahead of schedule have failed for now, with the US Patent Trial and Appeal (PTAB) ruling that a dosing patent shielding the multiple sclerosis drug should stand, rejecting challenges from Apotex, Argentum, Sun Pharma and Teva.
The four generics players “failed to show, by a preponderance of the evidence”, that claims 1-6 of US patent 9,187,405...
Generics Bulletin reviews global regulatory developments across the world.
Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
