Dosage Forms

Alan Sheppard is Principal, Thought Leadership, Global Generics at IMS Health.

Articles

Last year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.

The Biosimilars Market Today And Tomorrow

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalised this year to date.

EU generic applications down in 2010

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalized this year to date (9 and 12, respectively).

EU Generic Applications Down in 2010

Peter Wittner is an independent consultant.

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.

Biosimilars: Is It Worth Taking On The Regulators?

We speak to The European generic Medicines Association about the environment for biosimilars.

The European Generic Medicines Association

Peter Gaskin is Principal Consultant at Aptuit Consulting.

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.

Latest EU Guidelines For Biosimilars Dissected

Dr Pablo Fernandez is Senior Vice President, Medical Affairs, PharmaNet.

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 Changing Landscape For Biosimilars

Huub Schellekens is Professor in the Department of Pharmaceutical Sciences and Innovation Studies at Utrecht University, The Netherlands.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

What Is Hindering The Uptake Of Biosimilars?

David E. Szymkowski is Senior Director of Biotherapeutics at Xencor.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

True Biosimilars Do Not Offer A Compelling Business Case

The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis's displeasure.

Generic Drugs