Generics
Dr Reddy’s gears for semaglutide debut across markets, including India and Canada, where Novo Nordisk has second brands of the GLP-1 agonist potentially ready. Can the Indian group close out compliance queries from the Canadian regulator soon?
Sun Pharma’s generic Wegovy product has cleared regulatory review, positioning the company to enter India’s obesity drug market once patent protection lapses.
In line with previously disclosed launch and partnering plans for GLP-1 products, Lupin shook hands with Galenicum, securing commercial rights to injectable semaglutide.
Generics Bulletin reviews global regulatory developments across the world.
Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).
Biocon Biologics has become one of the most prominent global biosimilars firms since its buyout of former partner Viatris’ biosimilars business. With a rumored IPO instead making way for a merger with generics unit Biocon Ltd, the business’s chief Shreehas Tambe sets out the reasons for the move.
Following a rebrand in 2024 with a mission to expand to global markets, Latvia’s Olpha has started shipping cholesterol management drugs to Mexico after winning a government supply tender.
With needed funds in its pocket, Biocon is prepared to simplify and integrate its growing off-patent medicines portfolio under one roof.
Marking the latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa (icosapent ethyl), the US Supreme Court has agreed to review the litigation, which cuts to the heart of key issues around skinny-label generics and carved-out indications.
European CNS specialist rolls out a value-added methylphenidate and a first-to-market guanfacine generic as it sharpens its European ADHD strategy.
Amneal sees vertical integration of its biosimilars business, as well as global partnerships, as a key advantage to remain at the top of the game ahead of upcoming competition.
Sandoz says the next ten years will provide a “golden decade” of off-patent competition from which it is uniquely placed to benefit – despite a relative lack of fresh loss-of-exclusivity opportunities in 2026 and 2027.
Oxford-based Allos is scaling up its AI platform, which aims to revive investments into reformulating complex generics.
The planned submission marks a key regulatory step toward potential day-one launches in Europe.
A couple of months after leaving Hikma, former Custopharm CEO and Hikma injectables chief Bill Larkins has been named as the new president of Par Health’s injectables business.
As Denmark’s Orifarm announced the appointment of Jutta Schnirring-Mayer as chief business development and portfolio strategy officer – the latest in a line of management changes under new CEO Mads Fink Eriksen – the firm set out its ambitions to expand its European generics business.
Cosette Pharmaceuticals and Alembic Pharmaceuticals are among the latest firms to have benefited from 180 days of competitive generic therapy exclusivity under the US FDA’s CGT pathway. Since the first approval in 2018, almost 500 ANDAs referencing CGT products have been approved.
Generics Bulletin reviews the first year of Trump 2.0 and its impact on the off-patent sector, which was marked by both favorable and less beneficial movements by US president Donald Trump and his administration.
Viatris is entering the new year with several key achievements under its belt.
Biocon Biologics has announced a further settlement over Eylea (aflibercept) allowing launch of its Yesafili biosimilar in territories outside of the US and Canada early next year. Meanwhile, Biocon Limited has launched its liraglutide rival to Victoza and Saxenda in the Netherlands.