Disease Landscape and Forecast Insights

MARKET OUTLOOK The introduction of additional Crohn’s disease (CD) agents has shifted—and will continue to shift—market dynamics. The newer non-TNF biologics (Takeda’s Entyvio and…

With the availability of multiple approved products for the treatment of diabetic macular edema (DME) in the EU5, including Bayer HealthCare’s Eylea, Novartis’s Lucentis, Allergan’s Ozurdex,…

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…

Celltrion’s Herzuma (trastuzumab) is the first biosimilar of Roche’s blockbuster HER2-targeted therapy, Herceptin, to launch in Europe. This series tracks uptake of Herzuma and medical…

Payers play a significant role in defining the commercial success of biosimilars—as well as their reference brands—as they decide which products are granted formulary access and preferential…

Five TNF inhibitors, five biologics with alternative mechanisms of action, and two JAK inhibitors are approved for the treatment of rheumatoid arthritis (RA) in the EU5 (France, Germany, Italy,…

The Emerging Biosimilars Landscape offers extensive coverage of the global biosimilars development landscape. We track over 400 currently available and novel biosimilar products, detailing…

Rheumatoid arthritis (RA) treatment is typically initiated with cost-effective conventional DMARDs, such as methotrexate. The U.S. market for conventional DMARD-refractory RA patients is crowded…

Vascular endothelial growth factor (VEGF) inhibitors—approved agents Eylea (Regeneron) and Lucentis (Roche/Genentech), and off-label Avastin (Roche/Genentech)—are the treatment mainstays for…

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…

Introduction: The crowded U.S. rheumatoid arthritis (RA) market boasts nine different biologics representing five distinct drug classes, including the blockbuster tumor necrosis factor-alpha (…

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…