While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology
As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.
Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
Generics Bulletin previews the most noteworthy and anticipated events for May 2025.
Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.
Reflecting increased regulatory pressure and a wider drive towards the reshoring of pharmaceutical manufacturing to the US, Speranza has launched a new generics business called Lotus Therapeutics.
As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
Amid several insights into its expectations of biosimilar competition in 2025, Roche has confirmed the total amount it anticipates being shaved from its top line this year.
Despite industry-wide uncertainty surrounding the Trump administration’s interest in pharma-focused tariffs, Hikma has maintained its guidance for the 2025 financial year.
With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.
Denosumab competition is heating up in Europe, with four more companies this month gaining EMA endorsements for their Prolia and Xgeva biosimilar rivals.
During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.
Samsung Bioepis has revealed first-quarter figures that reflect recent launches driving growth for the Korean biosimilars developer.
Aeon Biopharma has picked up Revance Therapeutics executive Rob Bancroft to serve as its new CEO as it continues to pursue a biosimilar version of Botox. Meanwhile, Coherus has lost its chief commercial officer, as Viatris, Sandoz and Medicines for Ireland have announced new appointments.
Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.
The move adds another compound with the coveted 180-day exclusivity to Hikma’s portfolio for an undisclosed sum.
After announcing the agreement last month, Xbrane has now approved its deal with Alvotech as part of an extra general meeting.
The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.
With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.