Biosimilars in Europe: Pricing, Interchangeability and Policy


Instructor: Peter Wittner
Product ID: 706760
Training Level: Intermediate

  • Duration: 90 Min
As far as biosimilars are concerned, Europe led the way and the rest of the world, including the US, followed - but how did this happen? The webinar will explain how Europe’s EMA developed the first regulatory environment that allowed multiple competitors to enter the market and start to take market share away from the originators. It also looks at the effect of the increased competition, the moves to include biosimilars in tenders, the resultant impact on prices, how the originators fought back and where we are now.
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Why Should You Attend:

The EMA (European Medicines Agency) developed a regulatory framework that became part of EU legislation in 2004. Other jurisdictions later copied all or parts of the regulations, but the US took until 2011 to catch up with its own legal framework. This helped to kick-start the market for biosimilars in Europe ahead of most other parts of the world.

The early years of the biosimilars industry resembled the history of the generics industry. A combination of lack of familiarity with the concept of biosimilars, initially slow adoption and a fight back by the originators all contributed to slow progress. The problems faced by the pioneers included pricing, Interchangeability and public policy regarding biosimilars.

The webinar looks at how the pioneers dealt with these issues, the degree to which these problems still exist, how companies have devised ways to deal with them and what attendees can learn from this experience and use to their own advantage.

It is easy for new entrants to the biosimilars market to make mistakes that can be costly. For instance - to assume that all the European markets are the same since they are governed by the same regulatory rules.

It is also easy to assume that the biosimilars market is simply the younger brother of the generics industry and that what works in the one can just be copied to the other.

Sadly, life and the biosimilars market are not that simple! Assumptions like these can lead to serious (and expensive) problems.

Learn from this webinar how the companies operating in the European biosimilars market found ways to deal with the issues of what level to price their products, Interchangeability, government and healthcare providers’ policies and how you can apply these lessons to your own plans for European market entry.

Areas Covered in the Webinar:

  • Regulatory / legislative background - how Europe led the way
  • Pricing - what is the right level?
  • Customers - who are they?
  • National differences - are the markets all the same?
  • Tenders - are they worth competing in?
  • Interchangeability - is it the same as substitution or switching?
  • Interchangeability - how has the Interchangeability question affected the market?
  • Biosimilar Winners - who are they and what can we learn from them?
  • Originators - defence strategies that they have used
  • Policy at the European and national levels

Who Will Benefit:

  • Marketing department
  • Business Development
  • Strategic planners
  • Regulatory departments

From industries including:

  • Generics formulations
  • Generics API manufacturers
  • Biological manufacturers
Instructor Profile:
Peter Wittner

Peter Wittner
Senior Consultant, Interpharm Consultancy

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial aspects of generics with more than 30 years’ pharmaceutical experience. Before starting his own business, Peter headed the European sales and marketing departments of the UK generics companies Evans Medical and H.N. Norton, which later became part of IVAX.

He later joined the Indian generic leader Ranbaxy as Managing Director to help set up its UK business and then returned to consultancy work.
Peter is a regular speaker and trainer on topics related to generics and biosimilars.

His company Interpharm works with new market entrants on generic strategies, assists in business development for generic companies based outside the EU that are trying to enter the market and advises companies that are seeking to enlarge their product range.

While mainly oriented to the commercial side with services such as market intelligence and pricing overviews for example, Interpharm also advises on IP and patent issues as well as the legal background to the pharmaceutical industry in Europe and the US. In addition, Peter has increasingly become involved with biosimilars and has frequently spoken on the topic and run seminars on the subject.

On the other side of the equation, Interpharm has also worked with originator companies that are concerned with defending their major brands from generic incursion.

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