One of the main challenges is that the US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act, which was signed into law on 23 March 2010 by President Barack Obama) does not yet have a practical pathway with guidance defined by the FDA. However, the financial case for biosimilars will continue to serve as the main driving force for laying down the regulatory framework that facilitates approval of biosimilars in the US. Estimates have put European healthcare saving from approval of the first wave of biosimilar products at US$2 billion – a big incentive for speed one would think.

In addition to the issue of the lack of a practical pathway in the US are many other questions. What are the manufacturing hurdles to be overcome? Where can costs be contained in order to make biosimilars more cost-effective? How can cost and risk reduction help to allow for the development of biosimilars? How is the US regulatory pathway likely to affect the registration procedure for biosimilars? How will biosimilars be marketed?

These were some of the questions addressed by Dr Ronny Gal, Senior Analyst at Sanford C Bernstein, during the 9th EGA International Symposium on Biosimilar Medicines held in London on 14-15 April 2011 [1].

The series of five articles that follow attempt to answer these questions by giving a brief overview of the presentation titled ‘Biosimilars: from here to profitability: what was accomplished and what is yet to be done?’ given at the 9th EGA International Symposium on Biosimilar Medicines.

Related articles

Timing of the launch of biosimilars in Europe

How cheap will biosimilars need to be

The market for biosimilars

Biosimilar regulatory issues

Development of biosimilars

Manufacturing of biosimilars

EGA meeting London 2011: biosimilars competitiveness in the EU

Reference

1. Gal R. Biosimilar development is progressing, but bigger challenges are ahead. 9th EGA International Symposium on Biosimilar Medicines; 2011 Apr 14; London, UK.