Biosimilars - Pioneering the future

Several biological drugs will go off patent over the next years. In fact, biologics with estimated total sales value of USD 63 bn (approx. 40% of forecast market) are expected  to lose patent protection by 2015 globally, rising to more than USD 100 bn by 2020. The EU has been leading the world in the introduction of biosimilars since it approved the first biosimilar in 2006. The Biosimilars market is estimated to be worth USD 2-3 bn by 2015, up to USD 20 bn or more by 2020.

Biosimilars have the potential to revolutionize patient access to treatments of serious medical conditions by providing affordable high-quality biological drugs. Yet, there are significant hurdles to overcome in the successful development and commercialization of biosimilars. These range from long early-stage development processes to uncertainty in regulatory guidance and challenges in commercialization.

On 24th May 2012 in Brno, Czech Republic, during BioForum, one of the keynote speakers - Dr. Steffen Wagner, Head Commercial Operations Central & Eastern Europe at Sandoz - will present a talk: "Biosimilars - Pioneering the Future". Dr. Wagner, formerly Director Global Strategic Planning at Sandoz and Engagement Manager with McKinsey and Company's Pharmaceutical Industry Practice, will discuss the development process, key challenges, regulatory environment, requirements for successful commercialization and key success factors for companies in the field.

These are important issues to consider because of their impact on the biosimilar business model - which is fundamentally different from the traditional generic model. The development of a biosimilar is highly complex and requires significant investment. According to current estimates, it costs between $75 to $250 million to develop a biosimilar and it takes between seven and nine years. This compares to between $1 million and $3 million for a chemical generic. The production costs are also significantly higher for a biosimilar compared to a chemical generic.

Sandoz is the pioneer of biosimilars and the clear global leader, with 2011 biosimilar sales of USD 261 million (+32% versus previous year), representing nearly 50% of the worldwide regulated market.

In 2006, Sandoz launched the first-ever biosimilar product in the EU (recombinant human growth hormone somatropin), followed by recombinant human erythropoetin (epoetin alfa) in 2007, and GCSF (filgrastim) in 2009. Sandoz is the only company with three marketed biosimilars in Europe, and Sandoz's somatropin product is also marketed in countries and regions including the US, Canada, Japan, and Australia, under different regulatory pathways. Sandoz also has a strong biosimilar pipeline, with 8-10 molecules at various stages of development and a clear focus on monoclonal antibodies.

BioForum 2012 is a strategic event for investors interested in BioBusiness. During this two day event, the most distinctive biotech / pharma companies from countries like Poland, Czech Republic, Hungary, Lithuania, Latvia, Estonia can be met. This is what attracts investors looking for new, attractive investment opportunities, as well as sharing  the passion for new, bold investment opportunity creation. The organizer of Bio-Forum is Bio-Tech Consulting from Lodz, Poland (www.biotechconsulting.pl).

BioForum - Central European Forum of Biotechnology & Innovative BioEconomy
together with accompanying events will be held on
23-24th of May 2012 in the Conference Centre BVV Trade Fairs in Brno (Czech Republic).

more: www.cebioforum.com