After several stops and starts, biosimilars are making inroads in the U.S. biologic market. The FDA has established an approval pathway for biosimilars, while globally, biosimilar sales are expected to reach $24 billion by 2019.
So what does biosimilar market entry mean for biologic innovators? Are innovators doomed to major market share loss, as is often the case for small-molecule drugs coming off patent, or will the nature of a biologic and the condition it treats limit market share erosion?
This paper examines three case studies of biosimilar-like drug introductions in the United States, offering pointed insight on the specific circumstances and company tactics that affected market share.