PPT-Biosimilars: Regulation and Litigation

Agenda Key Regulatory Exclusivities for Biologics Additional Regulatory Exclusivities Patent Strategy for Biologics Comparison Between the 262k Pathway and the ANDA Pathway Comparison Between the 262k Pathway and the ANDA Pathway continued. Richard . Dolinar. , MD. Chairman, Alliance for Safe Biologic Medicines. Presented at the 58. th. . Consultation on. . International Nonproprietary Names . for . Pharmaceutical . Substances . Geneva, Switzerland. James C. Shehan. Hyman, Phelps & McNamara, P.C.. 700 Thirteenth Street, N.W., Suite 1200. Washington, D.C. 20005, U.S.A.. 202-737-9634 .  . jshehan@hpm.com. October 29, 2014. Agenda. BPCIA Overview. Presented by . the Alliance for Safe Bioloigic . Medicines & the Global Colon Cancer Association. . . . . Andrew Spiegel, Esquire. . . andrew.spiegel@globalcca.org. THANK YOU! . Knowledge Connect Slide Resource. This slide deck has been designed to be used as a central resource from which pertinent slides can be extracted as needed . and is not intended for use in its entirety. Practical Legal/Regulatory Considerations Arising In The Course Of The Pathway’s Implementation. John M. Engel, Esq.. Managing Partner. Engel & Novitt, . l. lp. The Law Firm That Knows Its Science. This program will include a discussion of off-label treatments and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.. Alice DOMINIQUE - M2 AREIPS. 1. Content. 2. Definitions. 3. What. . is. a . biological. . medicine. ?. Biological medicine = Biologic medical product . . . . = Biological . . . Open Access publications.  and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information on Sciences and technology ‘Open Access’, OMICS Group publishes 400 online open access . Dr Chris Deighton. Consultant Rheumatologist . Conflicts of interest. Advisory boards for . Hospira. and . Napp. Work with Pfizer, Janssen, . Abbvie. , Roche . Arguments for. We have been using . biosimilars. Presented at the . Latin American Biologics/Biosimilars Conference. Sao Paulo, Brazil. September 27, 2016. Harry L. Gewanter, MD, FAAP, FACR . Chairman, Alliance for Safe Biologic Medicines (ASBM). Richard . Dolinar. , MD. Endocrinologist, Chairman of the Alliance for Safe Biologic Medicines. Presented at the . Colorado . Biosimilars. . Educational Forum  . December . 6, . 2012. 2. The differences between Chemical Drugs and Biotech Medicines you . biosimilars. Prof. dr. Steven Simoens. Health economist. Conflict of interest. I . am one of the founders of the KU Leuven Fund on Market Analysis of Biologics and . Biosimilars. following Loss of Exclusivity (MABEL) . Are you looking to automate and manage your legal department or law firm? Then, MatterSuite is the best lawsuit management solution that caters to your needs and assists you in all aspects of your lawsuit, including litigation management, matter management, discovery, reporting, contact management, permission groups, calendaring, and much more. Make your legal department more efficient with an enterprise legal management (ELM) solution that supports multiple locations and languages.

For more details visit: https://www.mattersuite.com/litigation-management-software/ Disclaimer. This panel is moderated by Dr. Delphine Courmier, Executive Director Global Head of Pricing. & Biosimilars Market Access at Organon. The views expressed are those of the speakers and do not necessarily represent the views of ISPOR or Organon..