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U.S. Biosimilars

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Date: 20-Apr-15 to 21-Apr-15
Location: Sheraton Munich Arabellapark Hotel / Munich / Germany
Category: Banking, Finance & Investment Legal Services Conferences & Trade Fairs

Based on industry demand, ACI is bringing its flagship Biosimilars event to the EU companies who will be doing business in the US. As companies are officially moving forward with the first U.S. biosimilar applications, and the USFDA has given its stamp of approval to at least one, hear directly from the best of the US bar about how the major developments in US law will affect you.
The year’s major developments show that the time for speculation and hesitation have passed, and whether you are on the innovator or biosimilar side, you must have a plan for US biosimilar market entry.
For six years, since the passage of the historic Biologics Price Competition & Innovation Act (BPCIA) which first set the stage for biosimilars in 2010, the key figures shaping the evolving US biosimilars landscape have convened at our annual conference to formulate solutions to the challenges facing the industry. Don’t be left behind- arm yourself with an immediate action plan to prepare for the hard-fought battle to protect or increase market share which is sure to come.
Join us for an up-to-the-moment treatise on the significant regulatory and IP developments affecting US biosimilars. Event highlights include:
• Keynote address by Julia Pike, Head Global IP Litigation at Sandoz
• Comparing and contrasting the US and EU biosimilars experience to date to prepare and coordinate a global strategy based on insights from experts at AbbVie, Boehringer, IPM Biotech, PAREXEL, and more
• Meeting USFDA’s standards for biosimilarity and the heightened standard for interchangeability
• Evaluating the risk and commercial opportunity within the burgeoning US biosimilars market
• Obtaining adequate patent protection in the US in light of major changes to subject matter patentability and new USPTO patent office procedures
PLUS! A full day workshop designed to bring EU attorneys up to speed on the statute and the relevant governing bodies: Biosimilars 101.

Go to event website