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Pharmaceutical Technology Europe-08-01-2010
Pharmaceutical Technology Europe
Biosimilars: Is It Worth Taking On The Regulators?
August 01, 2010
Special Feature
22
8
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.
Pharma Takes Control Of Distribution Chains
August 01, 2010
Spotlight
22
8
Many pharmaceutical companies in the UK have adopted a direct-to-pharmacy distribution model, which enables companies to more tightly control their supply chains.
Is Your Packaging Line Operating To Full Capacity?
August 01, 2010
Packaging & labelling
22
8
Overall Equipment Effectiveness has been shown to identify the root cause of inefficiencies.
The New EMA Bioequivalence Guideline: Key Considerations
August 01, 2010
Regulation
22
8
A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.
The European Generic Medicines Association
August 01, 2010
Special Feature
22
8
We speak to The European generic Medicines Association about the environment for biosimilars.
Can Payers Afford To Watch And Wait?
August 01, 2010
22
8
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.
Sterile Production According To The New EU GMP Annex 1: A Focus On Capping
August 01, 2010
Manufacturing
22
8
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
August 01, 2010
Manufacturing
22
8
New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.
Latest EU Guidelines For Biosimilars Dissected
August 01, 2010
Special Feature
22
8
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.
The Changing Landscape For Biosimilars
August 01, 2010
Special Feature
22
8
As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.
What Is Hindering The Uptake Of Biosimilars?
August 01, 2010
Special Feature
22
8
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
August 01, 2010
Special Feature
22
8
Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.
Vacuum Conveying In The Pharmaceutical Industry
August 01, 2010
Ask the Expert
22
8
What are the newest trends in pneumatic conveying of pharmaceutical powders and blends?