12^th Asian Biologics and Biosimilars Congress

The biosimilars industry in the United States is still a nascent one. In 2015, FDA approved the  rst biosimilar biological product and several other approvals have followed, with more applications for other biosimilar biological products pending at FDA. Although FDA and industry are tackling the scienti c and data requirements for FDA to approve a so-called “Sectionn 351(k) application” for a biosimilar biological product, legal issues abound. Whether it is the requirements or the contours of the “Patent Dance” for resolving patent disputes between biosimilars applicants and reference product sponsors, the availability and the scope of 12-year reference product exclusivity or the appropriate naming convention for biological products, each issue is critical to the success of biosimilars in the United States and to the future of the industry. And with fast-paced litigation, the landscape for biosimilars seems to change on a monthly or weekly basis. This session will explore the ins and outs of current disputes involving the metes and bounds of the patent dance, non-patent exclusivity, naming and more; explain what each dispute might mean for the future world of United States biosimilars