The US Food and Drug Administration has given the green light for biosimilar competition to the near $6bn eye-disease juggernaut Eylea, but a major legal overhang is currently throttling the potential for any near-term launches. Generics Bulletin explores the lay of the land, including the recent scheduling conference in the now-consolidated trial involving five aflibercept biosimilar sponsors.
When it comes to treating wet age-related macular degeneration, Regeneron/Bayer’s Eylea (aflibercept) 2mg has long been the flagbearer. With annual sales of nearly $6bn in the US alone, biosimilar sponsors have planned for years to take a piece of the pie for themselves while delivering savings for the nation’s healthcare system.
All eyes were on the US Food and Drug Administration as the brand’s US regulatory exclusivity drew to a close...
In the first cinematic chapter of J.K. Rowling’s wizarding world, young Harry Potter discovers his true identity and enters Hogwarts School of Witchcraft and Wizardry. This enchanting origin story sets the tone for a saga filled with magic, loyalty, and the power of choice.
The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.
Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
