Biosimilars/Biobetters - BioPharm International

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Biosimilars/Biobetters

US Congress Acts on Follow-On Biologics and FDA Funding

July 24, 2007

In late June and early July, the US Congress moved forward on three important bills affecting the biopharmaceutical industry, related to follow-on biologics, the Prescription Drug User Fee Act (PDUFA), and the 2008 FDA budget.

Regulatory Beat: Campaign Accelerates for Follow-on Biologics

May 1, 2007

The information provided by analytical testing is important in determining whether additional clinical trails are necessary to bring a follow-on to market.

Regulatory Beat: Campaign Heats Up for Follow-On Biologics

December 1, 2006

The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.

Legal Forum: Patenting Strategies to Delay Biogeneric Competition

November 1, 2006

In the US, the patent term is 20 years from the filing date . . . commercial product may lose patent protection just as sales are ramping up.

Final Word: Omnitrope's Approval: What Does It Mean For Other Generics?

August 1, 2006

Congress is not considering legislation that would expand FDA authority to regulate biologics.

Final Word: The US is Falling Behind on Generic Biopharmaceuticals

June 1, 2006

Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.

The Best Targets for Biogenerics

April 1, 2006

Of all the protein products on the US market, at most 75 are likely to become genericized.

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