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There are new regulations affecting 576 biosimilars in development in the USA and Europe. This workshop will describe the new regulations for the purpose of obtaining delegate comments on whether the new regulations will have a positive or negative impact on biosimilar adoption in the market place. Once the impact is characterized, the workshop will develop several scenarios of biosimilar adoption resulting from the implementation of the new regulations.

  • To learn about the new regulations and the impact on biosimilars adoption
  • To meet the regulatory experts in biosimilars
  • To develop a business plan resulting from the implementation of the new regulations in the USA and/or Europe
  • To find a way to use the new regulations to improve your biosimilars business

Job titles include:
CSOs, CMOs, Heads, Directors, Managers, Team Leaders, from the following roles:
-Biopharmaceuticals/ Biotherapeutics
-Follow on Biologics/Follow on Proteins/Biosimilars
-Biologics/Biotechnology/ Biogenerics
-Legal and Regulatory Affairs
-Intellectual Property
-Pricing and Reimbursement
-Clinical operations
-Regulatory Compliance
- Drug Safety & Risk Management
-Quality Affairs/ Quality Control
-Drug Development
-Research & Development
-Portfolio Management
-Business Development
-Commercial Affairs and Strategic Planning

Workshop programme

13:30 Registration & Coffee

14:00 Opening remarks and introductions

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

14:10 Session 1 - Biosimilar Interchangeability: The newest regulation in the USA

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

In the USA only interchangeable products can be substituted for
the reference product by a pharmacist without the intervention of a health care provider. The interchangeability regulation is in the form of guidance:

  • Interchangeable biologics must be biosimilar to the reference biologic
  • If administered more than once, data must show the safety and effi cacy risks of switching
  • If not administered more than once, justify the omission of a switching study
  • The clinical data must demonstrate switching risk in a ll of the reference biologic’s licensed conditions of use
  • The data must support the “totality of the evidence” and “reduction of residual uncertainty”
  • Switching study design is defined and described in the guidance
  • Guidance describes what is insuffi cient to demonstrate interchangeability
  • The use of post-marketing data from a biosimilar
  • The presentation and design attributes must be the same to enable substitution
  • 14:50 Session 2- The impact of biosimilar interchangeability in the USA

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

  • An interchangeability rating may result in the perception that the product is superior in quality to other biosimilars
  • Where will an interchangeable biosimilar have the most impact?
  • How will payors react?
  • Likely competitor response
  • 15:30 Afternoon Tea

    16:00 Session 3 - The NOR-SWITCH Study in Europe on Interchangeability

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

  • Evaluate the efficacy and safety of switching from innovator infliximab (Remicade) to biosimilar
    infliximab (Remsima)
  • Primary endpoint: disease worsening
  • Secondary endpoint: safety, immunogenicity
  • One time switch
  • 16:40 Highlighting the Differences between EU and USA in Terms of regulatory Requirements

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

  • Introducing the 3 R principle to reduce animal studies
  • Introducing the Global reference Product notion
  • Extrapolation of Indications
  • No Interchangeability Requirement: this is in the Member States responsibility
  • Post-marketing surveillance Black triangle in EU
  • 17:20 Closing Remarks

    17:30 End of workshop


    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 



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    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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