Disease Landscape and Forecast Insights

The regulatory and market access landscape for biosimilars is constantly evolving. For a company seeking to develop a biosimilar for multiple markets, keeping track of the similarities and…

The development and commercialization of biosimilars require a significant investment in capital, resources, and time. Biosimilar developers must ensure that they are equipped with the necessary…

Inflectra (infliximab-dyyb), Pfizer/Celltrion’s Remicade biosimilar, became the first monoclonal antibody biosimilar to enter the U.S. market in late November 2016. Merck & Co.’s Renflexis (…

Truxima (rituximab), Celltrion’s MabThera biosimilar, became the first oncology monoclonal antibody biosimilar to enter the European market in April 2017. Two months later, Sandoz’s Rixathon, a…

In 2016, branded biologic sales in oncology, immunology, endocrinology, and nephrology across the major markets exceeded $70 billion. Sales from biosimilars in the same therapy areas and regions …

The Emerging Biosimilars Overview offers extensive coverage of the global biosimilar development landscape. We track over 350 currently available and novel biosimilar products, detailing…

Recent launches of Celltrion’s Truxima (rituximab) and Sandoz’s Rixathon (rituximab) have expanded the biosimilar sector of the European oncology market. In the United States, only a single…

Although ESA biosimilars entered the European market a decade ago, their uptake varies from country to country, as well as by drug and manufacturer. While European …

Immune biologics such as TNF-alpha inhibitors are among the most commercially successful biopharmaceutical products in the world, presenting a lucrative opportunity for companies to develop…

Recent launches of Merck & Co.’s Lusduna (insulin glargine) in Europe, and Eli Lilly/Boehringer Ingelheim’s Basaglar (insulin glargine) in the United States, have expanded the non-innovator…

There have been significant economic benefits in Europe since the approval of the first biosimilar more than a decade ago. Although the first FDA biosimilar approval was in 2015, biosimilars are…

In April 2017, Truxima (rituximab), Celltrion’s biosimilar of Roche’s MabThera, became the first oncology monoclonal antibody (MAb) biosimilar to enter the European market. In this series, we…