Biosimilars

Tuesday, June 07 to Wednesday, June 08, 2011

Millennium UN Plaza, New York, NY

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

The Biologics Price Competition & Innovation Act (BPCIA) was passed in March of 2010 and made the long-anticipated pathway to generic biologic products a reality at long last.  However, despite the passage of this historic legislation, the FDA has yet to implement regulations to guide branded and generic companies in structuring a biologics regime.  At ACI’s second-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:

• 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. 

Get the complete picture: The science, the law, the regulations and the international framework

Come away with a clear understanding of the scientific aspects of biosimilars at our pre-conference primer on Biologics Science 101:  Understanding and Breaking Down the Complicated Scientific Principles Behind Biosimilars.  At this in-depth session, leading scientists and academics will translate the technical and scientific complexities behind generic biologics into usable data to factor and incorporate into your business plan.   
Finally, complement your whole conference experience with our Master Class which will provide an In-Depth Breakdown of the Biosimilar Framework in the EU at which leading practitioners on the ground will dig into the regulatory and commercial specifics of the already-launched EU biosimilar framework.  Dive into the nitty-gritty details about launching biosimilars in the EU as well as best practices to implement based on the success of generic launches there.    

With all that is at stake, do not miss this opportunity to remain at the forefront of this pivotal growth opportunity into the long-awaited biosimilar market.  Register today by calling 888-224-2480, fax your form to 877-927-1563, or online

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Location:
Millennium UN Plaza
New York, NY