Biosimilar Development in Europe: Ten Years On
The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006.
The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, in the light of its experience.
In this special Pharmaceutical Technology Europe feature, Fiona Greer looks at what the future holds for biosimilars in Europe.
The Misinformation Maze: Navigating Public Health in the Digital Age
March 11th 2025Jennifer Butler, chief commercial officer of Pleio, discusses misinformation's threat to public health, where patients are turning for trustworthy health information, the industry's pivot to peer-to-patient strategies to educate patients, and more.
Navigating Distrust: Pharma in the Age of Social Media
February 18th 2025Ian Baer, Founder and CEO of Sooth, discusses how the growing distrust in social media will impact industry marketing strategies and the relationships between pharmaceutical companies and the patients they aim to serve. He also explains dark social, how to combat misinformation, closing the trust gap, and more.
Applying Porter’s Five Forces to Portfolio Management in Pharmaceutical R&D: A Strategic Roadmap
March 17th 2025The increasing costs and complexity of R&D in the pharmaceutical industry have necessitated the adoption of strategic portfolio management to optimize resource allocation and enhance competitive advantage.
