Pharmascience Appeals Canadian Copaxone 40mg Ruling
Mixed Verdict Involving Teva Sees One Patent Invalidated And Another Upheld
A mixed verdict in Canadian litigation involving Pharmascience has seen one patent protecting Teva’s Copaxone 40mg upheld and one deemed invalid. Pharmascience plans to appeal.
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Four patents protecting Teva’s Copaxone (glatiramer acetate) 40mg/ ml thrice-weekly formulation are invalid as obvious, the US Court of Appeals has confirmed in two parallel decisions. The decisions remove the threat of damages against Mylan and Sandoz, which launched glatiramer acetate (GA) 40mg pre-filled syringes ‘at risk’ pending Teva’s appeal (Generics bulletin, 16 February 2018, page 15).
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.