Patent Baristas

As Congress is considering possible legislation to create an abbreviated pathway for the FDA to approve generic biologic therapies (“biogeneric,” “biosimilar” and “follow-on biologics”), differences in the R&D expense and product cost, and the potential for both new therapies post-approval and second-generation innovations have raised questions about how to achieve the proper balance between innovation […]

Pointing out that Senators Obama and McCain agree on the need for affordable biologic medicines, Biologicsland now offers a game for testing your knowledge about biogenerics. Biologicsland, brought to you by Teva Pharmaceuticals, is an on-line board game where you pick a person to act as your player, like politician or scientist (and why is […]

It appears that no matter who wins the presidential election this November, both Barack Obama and John McCain back expanded use of generic drugs as a way to lower drug costs,  According to their advisers, both campaigns have pledged their support to help create a market for generic biotech drugs or biosimilars. As a part […]

Today’s Washington Post features a story on Ismed’s efforts to promote a follow-on biologics approval pathway here in Washington.  The article outlines the campaign by Insmed’s chief exec, Geoffrey Allan, to give Congress a lesson in biotechnology. The sudden outpouring of educational efforts on protein structures and drug pharmacology has to do with the fact […]

The Alliance of Minority Medical Associations (AMMA) and the Benenson Strategy Group held a national media briefing on poll results examining health care access and affordability in the US today. Dr. Randall Maxey, M.D., said that polling data show that most voters are unhappy with Washington and they are looking for change.  While Iraq and […]

Robert Shapiro, chairman of Sonecon, LLC, and former advisor to U.S. President Bill Clinton and British Prime Minister Tony Blair, has published a study on the potential savings when generic biologic treatments (biogenerics) find a pathway in the U.S.   I say when and not if since the government is the largest consumer of medical care […]

It appears, for now at least, that the legislation creating an approval pathway for follow-on biologics will not be included in the FDA Revitalization Act (FDARA). FDARA would reauthorize the Prescription Drug User Fee Act or PDUFA (pronounced puh-doo-fuh), which expires Sept. 30. PDUFA increases funding for the Food and Drug Administration through fees paid […]

In a long-awaited — and some would say long-feared — update in the regulatory pathway for FDA approval of follow-on biologics, the Senate’s Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which will address the scientific, regulatory and legal […]