Biosimilars

Tuesday, May 22 to Wednesday, May 23, 2012

TBD, New York, NY

Breaking news:  FDA releases draft guidance on biosimilars.  For the full report from the FDA Click Here

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Attend the one event where the industry leaders driving the business of biosimilars unite to set the standards which will shape an evolving legal and regulatory landscape

Hear what our prior delegates have to say about this event:

“One of the best CLEs I’ve been to in 10 years”
Maryann Wiskerchen, Counsel, Eli Lilly & Co. (prior delegate)

“Excellent program – informative and thought-provoking.”
Mark Bowditch, Patent Attorney, Sandoz Inc.

“I thought all the speakers did an excellent job in terms of content and delivery.”  Gregory York, Associate, Pearne & Gordon LLP

At ACI’s third annual Biosimilars conference, the key figures who are shaping the evolving biosimilar landscape--- leading policy makers, in-house representatives from branded and generic biotechnology and pharmaceutical companies, and top-tier litigators and patent prosecutors--- will convene to formulate solutions to the challenging questions left standing in the wake of the historic BPCIA legislation:

• Complying with the yet to be released FDA standards on the abbreviated biosimilars pathway requirements
• Meeting the heightened standard of interchangeability and proving or disproving similarity
• Delineating the scope of the exclusivity provision and analyzing the potential impact of the statutory 12-year period on research, innovation and consumer access to drugs
• Analyzing the complex patent resolution mechanisms outlined in the statute and proactively preparing for the intricate exchange process
• Ascertaining the volume and level of safety data that will be required to prove patient safety and efficacy to facilitate approval 
• Determining the financial viability of biosimilars and exploring alternative pathways to approval including biobetters

The major players are preparing for the inevitable--- the litigation and the attacks on biosimilar IP that are sure to come

With an estimated $100 billion in potential biologics sales at stake annually and a wave of patent expirations starting in 2014, there will be a hard-fought battle to protect and increase market share.  Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway.  Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins. 

Full conference details are on the way shortly.  If you are interested in speaking at this event, contact Nicole Cutrufello at n.cutrufello@americanconference.com.  For information on sponsoring or exhibiting at this event, contact Esther Fleischhacker at e.fleischhacker@americanconference.com.

Based on past success, spaces will fill up quickly. Register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering online at www.americanconference.com/biosimilars.

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Location:
TBD
New York, NY