The purpose of this Masterclass is to examine the regulatory barriers affecting biosimilar markets across Europe and the within the US.
Biosimilar markets are increasingly attracting more interest and are seen as a new industry for some generic companies to exploit, as these companies attempt to adjust to the high competition and low profit margins found in the commodity generics market. Less regulated markets have seen biosimilars take off in recent years; however this is not the case across Europe and the US where regulatory barriers have slowed the development of this industry in these markets.
SMi's masterclass hosted by Interpharm Consultancy, will address the common pitfalls in and around biosimilar regulatory requirements in both Europe and the US. Case study led and extremely informative, Peter Wittner looks to help identify both successful and unsuccessful applications in regards to biosimilar regulatory approval in a bid to better inform attendees of how they might approach.