PRLog - May 11, 2012 - Biosimilar development costs are high with some industry leaders claiming estimates of $100-150 million. Even after this substantial investment there is no guarantee of immediate return. With the FDA, America’s regulatory body, struggling to agree on a suitable approval pathway for biosimilars to reach market in the U.S. and similar marketing and associated costs to innovator drugs, biosimilars have their work cut out.
There is an alternative, as biobetters also aim to capitalise on well characterized target biomarkers and research on innovator drugs, but in addition, intend on improving the original drug to hold more beneficial properties. This strategy may not take advantage of accelerated approval pathways for biosimilars already in place in the EU, Japan and many other countries, but does give biobetters a competitive edge over innovator treatments.
Join SMi at their third Biosimilars and Biobetters conference that will discuss the impact of these new regulatory guidelines and their effects on approval of follow on biologics at this exciting event. There will also be discussions on the rising development cost of biosimilars and marketing and pricing strategies, with a focus on case studies from those who are both developing and distributing follow on biologics. You cannot afford to miss this event.
Key Benefits of Attending:
• Be informed of the latest news in biosimilar pipelines
• Evaluate current and future developments in intellectual property and patent protection
• Discuss the impact of recent guidelines issued by regulatory bodies such as the FDA and EMEA
• Asses commercial and financial strategies
• Consider market access pathways and strategies
• Develop plans and methods for biosimilar and biobetter drug design and clinical testing
This event will take place on 24th & 25th September at the Copthorne Tara Hotel, London. For more information http://www.smi-