米国のバイオ後続品を取り巻く環境

The U.S. biosimilar landscape is evolving rapidly, with three biosimilar products already available (Zarxio, Inflectra, Renflexis) and two more expected to launch by the end of 2018 (Amjevita and Erelzi). By 2020, there may be as many as 30 biosimilar products on the market in the U.S., targeting key indications in immunology, oncology, endocrinology, ophthalmology and pulmonology (Figure 1). Nearly half of biosimilar candidates in the pipeline are oncology products, including oncology therapeutics (bevacizumab, cetuximab, rituximab and trastuzumab biosimilars) and supportive care (biosimilar filgrastim, pegfilgrastim, and epoetin). The foundation for how the U.S. market will react to future biosimilar launches is being laid now, creating an opportunity for companies to shape the trajectory of biosimilars in the U.S., including their uptake, impact on corresponding innovator products and competition among multiple biosimilar versions of the same reference product. For example, there may be as many as five biosimilar versions of AbbVie’s Humira (adalimumab) approved in the U.S. by 2020, vastly complicating the therapeutic landscape. No matter what position a company plays in the biopharmaceutical market (innovator or not), biosimilars will bring new challenges. The key challenge companies must face is how they will adapt their product development and commercialization strategies to be successful.

Click here to read our Medical Affairs Perspective on Biosimilars