Surprise! Viatris Proves Its Worth With First Generic Restasis Approval
Complex Legal History And Development Challenges Surrounded Brand
Executive Summary
In one of the most keenly-watched markets, Viatris has emerged as the winner of approval for the first US generic version of AbbVie’s Restasis 0.05% ophthalmic emulsion, years after its IP was taken down. Numerous firms and analysts had acknowledged the complexity of the reference brand.
You may also be interested in...
Viatris Is ‘Not Walking Away’ From Generics
After reporting sliding sales for both generics and complex generics in Q1, Viatris has nevertheless reaffirmed its commitment to the off-patent sector, highlighting in particular a planned launch this year of its Breyna rival to Symbicort.
5 Talking Points As Sun's Cequa Hits Home Turf And There's Restasis
Cequa arrives in India, almost four years post US debut with Sun deploying what has generally been perceived as the text-book launch approach of foreign firms in the country. Scrip delves into the market dynamics in a segment where AbbVie's blockbuster Restasis is well entrenched.
Generic Drugs Outlined As ‘Significant Public Health Priority’ For FDA
The FDA Office of Generic Drugs has published its annual report, highlighting its contributions to the approval of Viatris’ generic cyclosporine rival to Restasis, alongside updates to bioequivalence standards and support for competition.