Although the first biosimilar was approved by the FDA in March 2015, many questions regarding how these products should actually be brought to market remain. In addition to the commercial considerations around pricing and access, manufacturers are also keeping a watchful eye on the unsettled regulatory issues that still exist including guidance around the naming of the drugs, extrapolation of indications, and interchangeability.
The 2nd Annual Biosimilars Market Access Summit brings together a multi-stakeholder faculty to address the regulatory and commercial issues that manufacturers must address when looking to bring these products to market in the U.S.
The 2nd Annual Biosimilars Market Access Summit brings together a multi-stakeholder faculty to address the regulatory and commercial issues that manufacturers must address when looking to bring these products to market in the U.S.
