Biosimilars - Contrasts Between European And US Markets
Peter Wittner, B.Sc., is an independent consultant specializing 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. Interpharm advises 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 works with 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.
On the other side of the equation, Interpharm has also worked with originator companies that are looking at ways of defending their major brands from generic incursion.
Biosimilars have become a worldwide industry with a few giants who have an international presence and a larger number of smaller players who are just active in a handful of markets. One curious aspect of the industry is that it has attracted both a few Big Pharma and many generic companies who now compete head-to-head with each other. The question then arises as to which side of the industry is better suited to deal with this relatively new sector of the pharmaceutical business?
Generic Companies? They have the following advantages:
- Faster to spot opportunities
- Used to working on low margins
- Experts at low-cost manufacturing
But...They are generally not skilled at marketing to doctors
Big Pharma? On their side, they have these advantages:
- Have the financial resources to develop
- Can manufacture biological products
- Know how to market to physicians
But.......They are usually slow to react to price issues.
There is no doubt that the generic industry dominated what might be called the "first generation" biosimilars that included Erythropoietin, Filgrastim, and Human Growth Hormone,
However, several of the companies that come into the "Big Pharma" category have also now developed and registered "second generation" biosimilars that include the Monoclonal antibody products.
This should set up an interesting trial of strength to see if Big Pharma can recapture the biosimilar initiative from the generic industry.
Europe and the US are very different in many ways and this is also true of their markets for biosimilars. This webinar gives an overview of some of the factors that have shaped the market for these products.
Course Level - Intermediate
Who Should Attend
Anybody wanting to obtain an overview and basic understanding of the issues involved in entering the markets for biosimilars in the US and Europe.
Why Should Attend
Biosimilars have attracted a great deal of interest recently and some observers have viewed them as the new generic frontier. It was widely thought that the high costs of clinical development work and regulatory barriers would result in lower levels of competition. This, in turn, it was assumed would lead to higher margins in an industry notorious for its generally low margins on commodity generics. The reality has been different.
Despite the need for expensive clinical work that is part of biosimilar development and the high regulatory barriers in Europe, to which can be added issues of interchangeability, there has been a large number of successful product launches. The market has become much more competitive than anybody expected with substantial price falls – even the originators have responded to competition by cutting their brand prices.
Europe led the way in creating a regulatory environment for biosimilars, whereas the US lagged several years behind. As a result, progress across the Atlantic has been much slower but the situation is changing with the long-awaited legislation and FDA guidelines now in place to simplify biosimilars registration.
Nevertheless, there are still far more biosimilars present in the European markets that are available in the US. The question remains though as to why has the market not developed in the way that the forecasters a decade ago expected? More importantly, how are the biosimilar markets of Europe and the US likely to develop in the next decade? How can you decide whether or not it is a market that you should consider entering?
This webinar provides an introduction to the regulatory environment and takes a look at the factors that have helped to shape the market as it is today. It also sets out to provide you with some insight into why the market has developed the way that it has done and looks at what the future might bring on both side of the Atlantic.