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Biosimilars – Understanding the Regulatory Processes and the Commercial Realities
2 October 2015
Biosimilars – Understanding the Regulatory Processes and the Commercial Realities

This workshop aims to give participants a good overview of the whole topic of Biosimilars while investigating some topics in more depth. Biosimilars have attracted a great deal of interest and represent a new generic frontier as it is thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins.

Lower regulatory barriers in less regulated markets have allowed a Biosimilars market to take off, but higher regulatory barriers in Europe and issues of interchangeability have resulted in slow progress for those already in the market. Across the Atlantic, the situation is changing with the long awaited legislation enabling the first Biosimilars registration. How will the market develop there as multinational players start to enter?

Workshop LEADER

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Peter Wittner

Senior Consultant, Interpharm Consultancy

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial aspects of generics with more than 35 years’ pharmaceutical experience. In one of his industry roles, he joined the Indian generic leader Ranbaxy as Managing Director to help set up its UK business before returning to consultancy work (http://www.interpharm-consultancy.co.uk).

He previously headed the European Sales & Marketing department of the UK generics companies Evans Medical, which later became Medeva, and H.N. Norton, which later became part of IVAX and subsequently Teva.

Peter is a regular speaker at generic conferences, has run Biosimilars workshops for a number of organisations as well as conducting training seminars. He has written a number of reports on generics industry topics.

Interpharm Consultancy

Interpharm Consultancy has been serving the generic pharmaceutical industry since 1997. With a background of over 20 years in generics, we specialise in:

  • advising on growth strategies or market entry strategies
  • helping with business development
  • competitive intelligence
  • providing a link between firms in the UK and overseas companies trying to gain entry into this very competitive marketplace
  • training on understanding the generic marketplace, IP and regulatory issues
  • locating products and registration dossiers for UK companies and
  • assisting branded companies to plan their defence strategies against generics
  • offering help to companies looking for generic acquisitions

Workshop agenda

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8:30

Registration & Coffee

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9:00

Introduction and Opening Remarks

Peter Wittner, Senior Consultant, Interpharm Consultancy

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9:15

Overview - Biosimilars? Biogenerics? Follow-on Biologicals?

  • What are we actually talking about?
  • Summary of issues affecting biosimilars
    - Regulatory
    - Commercial
    - Legal/IP
  • Interchangeability - what is the issue?
  • clock

    10:00

    The Regulatory process and its pitfalls

  • Europe: A straight forward case
    - EMEA guidelines
    - Overview of successful and failed applications
  • US: The juggernaut begins to move
  • India, China and other countries?
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    10:45

    Morning Coffee

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    11:15

    Biosimilars - The commercial reality

  • What is the big attraction?
    - Biologicals market and prospects
  • The story so far...
    - Europe and the USA
    - Asian markets and Latin America
  • Patents, IP and other issues
    - What are the patent issues?
    - Interchangeability - a potential roadblock
    - Differing national legislation
  • Where do Biosimilars gof rom here?
  • clock

    12:15

    Discussion and Q&A

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    12:30

    Close of Workshop

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    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. 

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    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. 

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    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.

    CPD AND PROFESSIONAL INSTITUTES

    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.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    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, SAE Media 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.

    GLOBAL CPD

    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@saemediagroup.com

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