Search results for " Europe" in Articles / App Notes
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
the US?
Rooke (Start Codon): In Europe, there remains some uncertainty about the Unified Patent Court and Unitary Patent package established by the EU. A constitutional challenge in Germany has …
Article
EMA Collaborates with HTA Assessment Networks
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a new drug is only a preliminary step in what can be a lengthy and complex procedure for some pha…
Article
Trends in BioPharma Approvals in 2013
A total of 16 approvals were recorded in Europe, while only six biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in th…
Article
Biosimilars: Making the Switch Comes with Challenges
By Sean Milmo
The use of biosimilars continues to increase strongly in Europe, 10 years after the first biosimilar, a somatropin, was approved by the European Union (EU). With approximately 20 new…
Article
Maximum Output Starts with Optimized Upstream Processing
KBI Biopharma, for instance, is implementing a global expansion strategy that includes bringing online new clinical and commercial manufacturing facilities in the United States and Europe.Vibalogics i…
Article
Biopharma in 2015: A Year for Approvals and Innovations
One of the most groundbreaking approvals occurred in March, when the FDA approved the first biosimilar in the US (years after the first such approval in Europe), Sandoz’s Zarxio (filgrastim-sndz). The…
Article
GMP Challenges for Advanced Therapy Medicinal Products
By Sean Milmo
A consultation period on GMP guidelines (1) in the European Union, specifically for advanced therapy medicinal products (ATMPs), comprising gene- and cell-therapy products and tissue-…
Article
Biomanufacturing Outsourcing Globalization Continues
Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America and Western Europe. Contract m…
Article
Ensuring the Quality of Biologicals
… of an already authorized original biological medicinal product (reference medicinal product) in the European Economic Area (EEA). The first biosimilar was approved in Europe in 2006, and there are n…
Article
Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…