As biopharmaceutical patents are beginning to expire, biosimilar products are starting to enter the marketplace. To date the EMEA has approved 14 biosimilars for use in the EU and has issued an established regulatory pathway for biosimilar approval. The financial incentives are high, strong opportunities are predicted for successful biosimilar developers with the added benefit of increasing access to life- saving medicines.
Although the potential rewards are high, unlike generics, 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. 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. 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 visit http://www.smi-online.co.uk/biosimilars-biobetters73.asp alternatively contact Fateja Begum on +44 0 207 827 6184 or email on [email protected]
About SMi Group
The SMi Group is a world leader in business to business information. With nearly two decades in the business, thousands of senior executives from blue chip companies have already benefitted from SMi’s highly targeted conferences, workshops and publications. For more information visit http://www.smi-online.co.uk