Challand Biosimilars Consulting To Present Key Factors For Successful Uptake In The Market At Biosimilars North America

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...

Latest FDA approval was Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases…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/ein 

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!

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. For more information, visit http://www.smi-online.co.uk.