Anjan Selz Takes SWOT at Biosimilar Market

A good article from Pharmaceutical Executive that presents a SWOT analysis of the biosimilar market, written by Anjan Selz, CEO of Finox AG. 

Some of the take home points for me.  First, pricing for biosimilars may be the first point of differentiation between a new entrant and the orginator compound, but the biosimilar manufacturer should consider how to build additional differentiation into its product. This is best done by askng the prescribing community and the patients to share their ideas of the "perfect product".  Then based on this information, look for opportunities to differentiate by for example, optimizing the formulation, changing delivery modes, packaging variants, sizes and service aspects of the product offering. 

Secondly, try to find targets for which you can access the knowledge around the product, its development and production processes, and then try to stay as close as possible to this foundation as this has proven its viability through the originator for many years.  You must find a way around IP issues or you may be taking part in a game too heavy to play for a small company.

Finally prepare for the unexpected. You have a high chance to run into additional costs while in development. These may result from a changing regulatory or IP environment, evolving market expectations or simply out of the fact that it is difficult to do everything right the first time.

Nobody said it was going to be easy.  The originators have an advantage at present in market experience and credibility.  However, the high number of originator biotech drugs coming off patent in the near future will put a continuous string of biosimilars onto the market.  Third party and government payer policies will also support their introduction to the market.

Posted by Bruce Lehr September 20th 2010.

Comments

[Ashritha]

My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
Various issues have been dealt with, such as:
- Patent expirations
- Regulatory frameworks
- Infrastructure Requirements
- Etc.
If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

[bigredbruce]

The Pharmalot blog reports that the FDA will be holding a two day seminar on biosimilars on Nov 2nd and 3rd in Silver Spring, MD.
http://www.pharmalot.com/2010/09/fda-to-hold-a-two-day-meeting-on-biosimilars/
The meeting is the latest signal that the FDA is formulating a policy toward approving biosimilars, a topic that greatly concerns drugmakers, insurers, doctors, investors and policymakers, among many others, given the potential for huge disparities in price between brand-name meds and copycats. The move comes after Congress earlier this year gave the FDA a green light to approve biosimilars