Tag Archives: biosimilars

Biosimilars Ahead, Proceed with Caution

Richard Dolinar

By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong Read More >

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Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention

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In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation. Read More >

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BIO IP Counsels Conference Agenda Topics

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Join us in Austin for BIO’s Intellectual Property Counsels Committee Conference on April 16-18.  Agenda topics are below. The Decline of Process Patents: This session will examine the enforceability of process claims and how it has led to the recent controversy around divided infringement. Unlike claims to machines, manufactures, and compositions, process claims can be divided up by different actors, or by jurisdiction, and conceivably even by time.  Right now the focus is on different Read More >

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BioCentury TV at BIO International Convention

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BioCentury TV interviewed biotech leaders throughout the recent BIO International Convention in Washington, DC. The first interview can be found here (links to the other interviews can be found on the right). (July 24) Public+Private Part 1 — Turning Great Science into Medicine — and Jobs: Dr. Michel Goldman of Europe’s Innovative Medicines Initiative xplains how the pharma-driven agenda is creating a new “ecosystem” in Europe for drug developers. (July 31) Public+Private Part 2 – Read More >

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Biologics & Biosimilars: What is the Science Telling Us?

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Panelists from the varied backgrounds of academia, business and regulation agreed on the highest scientific standards of biosimilar regulation. Each panelist emphasized the need for the most stringent of standards in order to ensure patient safety and efficacy within the emerging biosimilars market. As Brian Liang, Executive Director of the Institute of Health Law Studies at California Western School of Law, summed it up, “the need in biosimilars is to focus on science, not cost. These are Read More >

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