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Novartis : Sandoz Head of US Regulatory Affairs Explores New FDA Biosimilar Interchangeability Guidelines

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06/29/2017 | 09:01am CEST

Iselin, NJ, June 29, 2017 --(PR.com)-- SMi Group has announced that Dr Cindy Cao, Executive Director and Head of US Regulatory Affairs for Biopharmaceuticals at Sandoz has joined the speaker panel for the 4th Biosimilars North America, which takes place on November 15 & 16, 2017.

Earlier this year, the FDA released a highly-anticipated draft of guidelines for biosimilar interchangeability. Months later, more than 50 stakeholder groups have submitted comments on the draft guidance. Comments suggested that the agency still needs to clarify the standards for naming and labelling, as well as showing that a biosimilar is, indeed, interchangeable with the original biologic. Dr Cao’s presentation will aim to address questions relating to the FDA guidelines.

Speaking on Day 1 of the conference, Dr Cao will discuss the FDA's biosimilar interchangeability guidance. In her presentation, she will discuss the impact of the new guidelines and explore considerations for interchangeability, as well as how to engage with stakeholders.

Dr Cao joins a speaker lineup comprised of experts shaping up the biosimilars landscape in North America including representatives from Sandoz, Mylan, Harvest Moon Pharmaceuticals, Momenta, FUJIFILM Diosynth, Oncobiologics, Adelio, Covance, Zuckerman & Spaeder and more.

The full roster of speakers and their topics can be found on www.biosimilars-northamerica.com/prcom.

This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.

Registration is now live on the event website and there are currently Early Bird rates available.

4th Biosimilars North America
November 15 & 16, 2017
Renaissance Woodbridge Hotel, Iselin, NJ, USA

For delegate registration enquiries, contact Fateja Begum on [email protected] For media enquiries, contact Honey de Gracia at [email protected]

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

Contact Information:
SMi Group
Honey de Gracia
+44 (0) 207 827 6102
Contact via Email

Read the full story here: http://www.pr.com/press-release/721481

Press Release Distributed by PR.com

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Financials ($)
Sales 2017 48 383 M
EBIT 2017 11 853 M
Net income 2017 7 439 M
Debt 2017 15 454 M
Yield 2017 3,31%
P/E ratio 2017 25,68
P/E ratio 2018 22,62
EV / Sales 2017 4,94x
EV / Sales 2018 4,72x
Capitalization 223 476 M
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Number of Analysts 32
Average target price 82,4 $
Spread / Average Target -3,5%
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Joseph Jimenez Chief Executive Officer
Hans Jörg Reinhardt Independent Non-Executive Chairman
Harry Kirsch Chief Financial Officer
Vasant Narasimhan Chief Medical Officer & Head-Drug Development
Srikant Madhav Datar Independent Non-Executive Director
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