SMi's 3rd annual Biosimilars North America conference will be returning to Iselin, New Jersey, USA in November 2016. This year’s event promises to bring even more senior experts discussing industry hot topics such as: latest approvals, biosimilar commercialization, interchangeability’s impact on biosimilars, regulatory updates and much more!
SMi Group is delighted to announce: Rodeina Challand, Director, Challand Biosimilar Consulting joins the 3rd annual Bisoimilars North America conference.
The regulatory pathways for the approval of biosimilars are well developed and tested globally... The EU is the first region in the world to have set a legal framework and a regulatory pathway for biosimilars. To date, EMA has approved 22 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoiesis stimulating agent, follicular hormones, insulins and monoclonal antibodies for use in the EU. The legislative route creating biosimilars for the US market was created by the enacted healthcare reform law, the Patient Protection and Affordable Care Act (PPAC Act), signed into law in March 2010. The new law also included a pathway for an interchangeable biosimilar, which is a biological drug that can be automatically dispensed without specific prescriber authorization...
The exponential rise of biosimilars in clinical trials and applications for FDA approval continues to rise. ...The challenge is successful uptake in the market.
Rodeina’s presentation topics will include: payer policies; regional variation- lack of optimization; education; clinical package; interchangeability/ naming; the price; the patent dance.
The full presentation details are available at: www.biosimilars-northamerica.com
Speaker line-up 2016 : Harvest Moon Pharmaceutical USA, Teva Pharmaceuticals, Amgen, Inc., Sandoz, Vizient, Abzena, Schwegman Lundberg Woessner, Wyatt Health Management, Orygen Biotechnologia, Janssen R&D, Boehringer Ingelheim, MKTX Market Access Solutions, UBC - An Express Scripts Company, and many more!
Day one will address the regulatory updates, commercialization: lessons learned in Europe and worldwide, while Day two will explore the technological developments, commercialization strategies and market development, through a series of exciting panel discussions, presentations and workshops.
Don't miss the great opportunity to network with the leading industry experts and learn how to ensure both clinical and commercial success to replenish the pipelines – places are filling fast!
If you would like to join Biosimilars North America as a sponsor or exhibitor, contact Alia Malick on +44 (0) 207 827 6168 or by e-mail: email@example.com
To register please get in touch with Fateja Begum: firstname.lastname@example.org; +44 (0) 20 7827 6184
Biosimilars North America
16-17 November 2016
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
#USABioSMi | @SMIPHARM
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About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
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Last updated on: 18/10/2016
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