Biosimilars Global Congress 2016 Europe
26 Sep,2016 - 28 Sep,2016
Hilton London Kensington Hotel, London, UK
A Little Teaser
Biosimilars is a type of biological product that is similar to another drug, which has already been approved by the US FDA or European Medicines Agency. Due to their high degree of similarity with the biological reference product, they have no clinically evidenced and meaningful differences from the reference product in terms of quality, safety or efficacy.
The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.
However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.
In this congress, we will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.
Gain Latest Insights on;
- Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to the market
- Know the strategies in place in developing and manufacturing biosimilars in emerging markets
- Establishing and integration of biosimilarity and comparability into developing Biosimilars
- Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
- Explore CMC regulatory challenges and considerations for Biosimilars drug development and manufacturing
- Study the pre-clinical and clinical challenges associated with the development of biosimilars
- The importance of establishing partnerships and successful collaboration for Biosimilars business
- Learn the latest updates, trends and current Biosimilars market situations in different regions
- What does the future hold for Biosimilars and Biologics
- Network with experts and leading drug developers, regulators and investors in the industry