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 To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, in the light of its experience.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.
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
Asembia 2025: Therapy Advancements Highlight Growing Cost and Access Concerns
April 30th 2025Fran Gregory, VP, emerging therapies, Cardinal Health, discusses the evolving cell and gene therapy landscape, highlighting pipeline growth, cost challenges, and emerging therapeutic areas beyond oncology and hematology.
