Biosimilars

With the election over and PPACA firmly established as law, the rush to the biosimilar market has begun in earnest.  At ACI’s fourth 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 legislation:

• Complying with the FDA standards on the abbreviated biosimilars pathway requirements
• Meeting the heightened standard of interchangeability and outlining the parameters of similarity in the contextof large complex biological compounds
• 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 debate over naming and the new bills introduced restricting the ability of pharmacists to substitute generic versions of biological drugs for brand name products
• Investigating the impact of citizen’s petitions on the biosimilars market

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

With a now estimated $140 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. 

Hear What Prior Attendees are Saying about this Annual Leading Event:

-  “One of the best CLEs I’ve been to in 10 years”

-  “Excellent program – informative and thought-provoking.”

-  “I thought all the speakers did an excellent job in terms of content and delivery.” 

-  “Excellent seminar.  A lot of learning, new points of view talked about and dealt with.”

Full conference details are on the way shortly.  If you are interested in speaking at this event, contact Nicole Cutrufello-Turner 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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