Search results for " Europe"
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…
Article
Climate Change in Outsourcing
On the negative side, governments and private insurers, especially in Europe but increasingly in the United States as well, have forced down the prices they are willing to pay for drugs and are refusi…
Article
Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Levine sees a similarity between the new FDA guidelines and the current guidelines in Europe. “They follow very closely along the lines of the EU law,” he says. Levine notes however that there are a f…
Article
Contract Manufacturing Through the Years
The generic API business was still dominated by European companies, and custom manufacturing was a small piece of the business as the global bio/pharma companies had large internal laboratories and ma…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The European Medicines Agency (EMA) approved the first mAb biosimilar developed by Celltrion and Hospira in 2013 (infliximab: Remsima/Inflectra). Development of clear, regulatory approval pathways for…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…
Article
Trends in Downstream Bioprocessing
• European respondents reported slightly less concerns vs. US respondents concerning chromatography (17.7% for U.S. vs. 14.8% for Europe). In 2009, 33.3% of Western Europeans vs. 14.5% of U.S. respond…