SMi’s 10th Annual Biosimilars Conference

Conference:  Wednesday 25 and Thursday 26 September 2019

Workshop: Tuesday 24th September 2019

Location: Copthorne Tara Hotel, London, UK


Chaired by Michel Mikhail, International Expert Regulatory Affairs, Global Expert Biosimilars

Discussing future regulatory, commercial and legal challenges of biosimilars

SMi Group are delighted to announce the 10th annual Biosimilars Conference taking place on 25th and 26th September 2019. This year’s event will be our first global event taking place in London, UK. The event’s focus is to highlight the current challenges in the biosimilars market and discuss current undergoing plans or developments to overcome these challenges.

The biosimilars market is forecasted to reach USD$23.6B by 2023 at a compound annual growth rate (CAGR) of 31.70%. Factors driving the increase of this market include growing demand for biosimilar drugs due to their cost-effectiveness, growing incidence of chronic diseases, and strategic collaborations resulting in enhanced productivity and clinical trial activities.

With the expiry dates of major patents fast approaching, the emerging gap in the market for biosimilars is now a major attraction for manufacturers. As the availability of biosimilars could potentially reduce direct spending by USD$54B by 2026, the question is what can current biosimilar producing companies do to join this market to benefit the patients, physicians and investors?


  • HEAR about current strategies under development to overcome challenges with patents currently faced by many biosimilar developers
  • DISCUSS the possible changes in regulatory approval of biosimilars in the UK post Brexit, and how this will impact market entry
  • EXPLORE the latest methods in use to maintain the relationship between stakeholders, doctors and patients, with the influence of governing bodies
  • REVIEW FDA regulations for the approval of Biosimilars and the latest approvals


Tuesday 24th September 2019, Copthorne Tara Hotel, Central London, UK

A: US-FDA Interchangeability Guideline

08.30 – 12.30

Workshop Leader: Michel Mikhail, International Expert Regulatory Affairs, Global Expert of Biosimilars

B: Global Development of Biosimilars – what can the US learn from Europe’s Strategies to promote biosimilar uptake

13:30 – 17:30

Workshop Leader: Rodeina Challand, General Manager, Challand Biosimilar Consulting


Presidents, Vice Presidents, Managing Directors, Directors, Associate Directors, Chiefs, Heads, Principals, Managers and Analysts of:

Biosimilar Development

Product Development


Market Access

Medical Affairs

Intellectual Property



Research and Development



Business Development

Strategic Marketing

Drug Development

Clinical Trials

Immunogenicity Studies

For information and to register visit

SMi’s 10th Annual Biosimilars Conference

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