Who can expect difficult competition in the biosimilars market?

A recent article at the Biotech Blog looks at a few of the segments they expect to see extensive competition in when it comes to the biosimilars market.

-Human growth hormones
-Recombinant insulins and modified recombinant insulins
-Follow-on versions of epoetin alfa
-Leukine®
-Drugs to combat neutropenia
-Interferon-alfa based treatments
-Rheumatoid arthritis treatments

Under current legislature, biologics automatically have 12 years of exclusivity, but after that, biosimilars can be introduced to the market. Do you agree that the areas above face the most competition? If not, what areas do you expect to see face competition?

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Biosimiliars 2009 Speaker Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs

Kevin E. Noonan of Patientdoc.org writes that, Professor Henry Grabowski has been cited often in the data exclusivity debate, on the economic justification for a twelve-year data exclusivity period for biologic drugs. Dr. Grabowski (at right), a Professor at The Fuqua School of Business at Duke University, has some credibility (in addition to his academic credentials) for having the only peer-reviewed analysis of the topic (his paper, "Follow-on biologics: data exclusivity and the balance between innovation and competition," was published online in Nature Reviews Drug Discovery on May 12, 2008). Opponents cite his support by the Pharmaceutical Research and Manufacturers of America (PhRMA) as raising issues of impartiality (albeit in the face of frankly partisan contrary opinions that have not faced peer review). Under the circumstances, it is important to the debate that everyone be familiar with the assumptions, analysis, and conclusions presented by Professor Grabowski.

Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs

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Business of Biosimilars Event

The biosimilars debate is intensifying with Ted Kennedy’s new proposed legislation for 13.5 years of data exclusivity for biologics – almost double the time period proposed by the Obama administration. With the cost of US biologics already topping $60 billion and rapidly growing, there is increased pressure to approve a regulatory pathway for biosimilars.

Are you prepared to compete in this complex and controversial environment? The Business of Biosimilars Event will help answer your key questions and address the risks and rewards of entering into this dynamic market.

*Understand current legislation & regulatory developments

*Evaluate exclusivity periods and their impact on competition

*Prepare to overcome regulatory challenges with insights and updates from a former FDA representative

*Examine the current regulatory pathway in Europe with case examples of approved biosimilars and developments from the EGA

To view the full agenda click here!

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