Generics Bulletin Originals
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Generics Bulletin previews the most notable and anticipated events for September 2023.
Generics Bulletin previews the most notable and anticipated events for August 2023.
Generics Bulletin previews the most notable and anticipated events for July 2023.
Generics Bulletin previews the most notable and anticipated events for June 2023.
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.
Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.
Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.
As Biocon Biologics completes its integration of the biosimilars front-end business that it acquired from former partner Viatris, Biocon founder and chairperson Kiran Mazumdar-Shaw talks to Generics Bulletin about how the firm is now capturing the full value of its biosimilars, while also looking at expanding into new markets previously unserved by Viatris.
With multiple generic molecules experiencing treble-digit-percentage price increases in the UK in August, betahistine tablets led the month’s biggest risers, according to WaveData.
July brought UK price spikes for multiple presentations of generic olanzapine orodispersible tablets. Market researcher WaveData reveals the reason behind the increases.
Amid triple-digit-percentage average price rises for several generic molecules in the UK during June 2023, pantoprazole topped the list.
Three presentations of olanzapine orodispersible tablets topped our table of the UK generics market’s Biggest Risers for May 2023.
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