Biosimilars/Biobetters - BioPharm International

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Biosimilars/Biobetters

What Follow-on Biologics Mean for the Future of the Biotechnology Industry

November 1, 2007

The industry needs a clear regulatory pathway for the approval of biosimilars.

Protein Therapeutics and the Regulation of Quality: A Brief History

October 1, 2007

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Biotech Manufacturers Face Competition from "Similar" Follow-Ons

August 1, 2007

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.

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.

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