Disease Landscape and Forecast Insights

In 2019, sales of branded biologics in oncology, immunology, endocrinology, nephrology, respiratory, and ophthalmology exceeded $100 billion in the major pharmaceutical markets under study (United…

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

MARKET OUTLOOK With the launch of five adalimumab biosimilars into the European market since October 2018—Amgevita (Amgen), Imraldi (Biogen), Hulio (Mylan), Hyrimoz (Sandoz), and Idacio (…

Biologics approved to treat immune indications (e.g., rheumatoid arthritis, Crohn’s disease) are among the most commercially successful biopharmaceutical products and offer a great opportunity…

In July 2019, Amgen’s Kanjinti (trastuzumab biosimilar) and Mvasi (bevacizumab biosimilar) were the first monoclonal antibody (MAb) biosimilars launched in the United States. Between mid-…

Erythropoiesis-stimulating agent (ESA) biosimilars entered the European market a decade ago, but only one ESA—Retacrit—has launched in the United States, and it did not launch until November…

The biosimilar/noninnovator sector of the endocrinology market is evolving. Eli Lilly/Boehringer Ingelheim’s Abasaglar/Basaglar was the first biosimilar/noninnovator insulin glargine to launch in…

Since the approval of the first biosimilar in Europe more than a decade ago, the use of biosimilars has been increasing in that region. Likewise, the FDA approved the first biosimilar in 2015, and…

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…

Celltrion’s Herzuma was the first biosimilar of Roche’s Herceptin, a blockbuster HER2-targeted therapy, to launch in Europe. A few months later, three additional trastuzumab biosimilars…

With the launch of four adalimumab biosimilars into the European market in October 2018—Amgevita (Amgen), Imraldi (Biogen), Hulio (Mylan), and Hyrimoz (Sandoz)—competition within the already…

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…