Biooutsource

Biosimilars have caused a revolution in the development of biologic drugs

Remsima Case Study: The importance of ADCC in assessing clinically relevant differences Authors: Dr. Daniel Galbraith, Chief Scientific Officer and Andy Upsall, Director of Technical Services – BioOutsource Ltd. The Regulatory Authorities Verdict “Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental …

Bloomberg Biosimilar Survey

Take part in the Biosimilars Survey – Bloomberg Intelligence

Bloomberg Intelligence have launched the Biosimilars Survey. This is your opportunity to have your voice heard. Take part in the survey here > All responders will receive a white paper and analysis of the results. That’s not all! All responders will also receive a 15% discount code off the delegate ticket price for World Biosimilar Congress USA 2015, where Bloomberg will be …

Designing, Clinical, Program, Biosimilar, Personal, Perspective,

Designing a Clinical Program for a Biosimilar: A personal perspective

At the Biosimilar Drug Development World Europe event 2014, Uwe Gudat, Merck Serono, gave a presentation on “Designing a Clinical Program for a Biosimilar: A personal perspective ” Download and learn: Innovator Clinical Development: A primer Biosimilar Clinical Development: Basics Biosimilar Clinical Development: Details Biosimilar Clinical Development: Conclusions Download Presentation Found this interesting? Join us at next year’s Biosimilar Drug Development World …

Obstacles, Opportunities, Biosimilars

Obstacles and Opportunities in Biosimilars

At the Biosimilar Drug Development World Europe event 2014,  Sophie Opdyke, Pfizer, gave a presentation on “Obstacles and Opportunities in Biosimilars” Download and learn: Obstacles Multiple Approaches To Clinical Development Interchangeability and Automatic Substitution Biosimilar Naming Download Presentation Found this interesting? Join us at next year’s Biosimilar Drug Development World Europe event happening this 4-5 March in Madrid.  The 4th annual Biosimilar …

clinical, pharmacology, biosimilar, biosimilars, biosimilar drug development congress

Biosimilars: A Clinical Pharmacologist’s view

At the Biosimilar Drug Development World Europe event 2014, Malcom Mitchel, Senior Medical Fellow, Eli Lilly, gave a talk on “Biosimilars: A clinical Pharmacologist’s view”. Download and learn: Method of administration Subject disposition Secondary PK analysis Conclusions on clinical pharmacology Best study Download Presentation Found this interesting? Join us at next year’s Biosimilar Drug Development World Europe event happening this 4-5 …

Cadila’s biosimilar at 20% of Humira price

You heard it right, the new biosimilar of adalimumab (brand name: Humira by Abbvie) was launched by Zydus Cadila with the name of Exemptia in India. This is the first biosimilar of adalimumab which is currently priced at one-fifth of Humira’s. (Read full article here) Biosimilars are significant biopharmaceutical products in  many countries in Asia. These biological products are similar, or  highly …

30 mins, biosimilars, world

Around the Biosimilars World in 30 Minutes

At the Biosimilar Drug Development World Europe event 2014, Klaus Martin, Polpharma, gave a presentation on “Around the Biosimilars World in 30 Minutes” Klaus Martin’s presentation attempts to answer key questions such as  “Is there a biosimilars market? And Where?” “Where are we with naming of Biosimilars?” and  “How to get to biosimilarity?” Download and learn: Market themes Regulations Development IP Summary …

obstacles, global development, biosimilars

Regulatory provisions as facilitation and obstacles to global development of biosimilars

At the Biosimilar Drug Development World Europe event 2014, Andrea Laslop, AGES PharmMed gave a presentation on “Regulatory provisions as facilitation and obstacles to global development of biosimilars” Download and learn: Biosimilar regulation in EU Biosimilar regulation/approvals in other regions Joint approaches – the biosimilar “cluster“ Summary Download Presentation Found this interesting? Join us at next year’s Biosimilar Drug Development …