OR WAIT null SECS
September 01, 2010
Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
In light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.
Many hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies will be asking themselves.
Last year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.
August 01, 2010
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.
We speak to The European generic Medicines Association about the environment for biosimilars.
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.
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 biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.