Pharmaceutical Technology Europe, Aug 1, 2010 - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Technology Europe, Aug 1, 2010
Special Feature
The Changing Landscape For Biosimilars
By Dr Pablo Fernandez
As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.
The European Generic Medicines Association
By Suzette Kox
We speak to The European generic Medicines Association about the environment for biosimilars.
Latest EU Guidelines For Biosimilars Dissected
By Peter Gaskin
The EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.
Biosimilars: Is It Worth Taking On The Regulators?
By Peter Wittner
The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.
What Is Hindering The Uptake Of Biosimilars?
By Huub Schellekens
The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.
True Biosimilars Do Not Offer A Compelling Business Case
By David E. Szymkowski
Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.
Manufacturing
Sterile Production According To The New EU GMP Annex 1: A Focus On Capping
By Dr Andreas Mangel
The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.
New Technologies For Pharmaceutical Manufacturing: Addressing Cost, Containment And cGMP Requirements
By Melanie Beck
New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.
Packaging & labelling
Is Your Packaging Line Operating To Full Capacity?
By Richard Stone
Overall Equipment Effectiveness has been shown to identify the root cause of inefficiencies.
Regulation
The New EMA Bioequivalence Guideline: Key Considerations
By Peter Langguth
A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.
Ask the Expert
Vacuum Conveying In The Pharmaceutical Industry
By Sharon Nowak
What are the newest trends in pneumatic conveying of pharmaceutical powders and blends?
Spotlight
Pharma Takes Control Of Distribution Chains
By Faiz Kermani
Many pharmaceutical companies in the UK have adopted a direct-to-pharmacy distribution model, which enables companies to more tightly control their supply chains.
News
News
Are you ready for Pharma 3.0?
Editor's Comment
Can Payers Afford To Watch And Wait?
By Fedra Pavlou
The interest in developing biosimilar medicines has grown dramatically in recent years with biotech drugs gradually increasing their share of the overall therapeutics market worldwide to account for an attractive portion of the sales pie.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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