Biosimilars are potentially disruptive to the pharmaceutical industry; the biosimilars sector not only allows extremely lucrative commercial opportunities for biosimilar companies but also poses an immense threat to innovator companies. Regulatory and commercial events that occurred in 2014 mean that biosimilars are set to become an imminent reality in the United States. Furthermore, owing to increased global development of biosimilar regulatory guidelines and approval pathways during 2014, the future biosimilar opportunity is only set to grow.

Companies are aggressively developing biosimilars to leverage the healthcare austerity environment by offering lower-cost biologics and, in doing so, make payers partners for the uptake of these products. To gain maximum uptake, biosimilar manufacturers need to be aware of the competitive landscape and challenges associated with biosimilar product development. As a result, biosimilar companies are honing their strategies and evaluating appropriate alliances and clinical trial designs. From the innovator side of the industry, companies are adopting measures to limit the negative impact that biosimilars pose to their brands.

In this report, we focus on the key clinical, corporate, and regulatory events affecting the industry in 2014. Key events that stand out include the EMA approval and tentative FDA approval of Eli Lilly and Boehringer Ingelheim's insulin glargine product, the first follow-on insulin approved in the G7 markets; FDA acceptance of biosimilar applications from Sandoz, Celltrion, and Apotex, and progress in the development of biosimilar approval pathways in Russia and China. These events highlight the dynamic nature of the biosimilar industry and signify imminent change to the size of the biosimilar industry.

Questions Answered in This Report:

  • Events in Q1 2014 included notable regulatory approvals; Celltrion’s biosimilar trastuzumab and biosimilar infliximab were approved in South Korea and Canada, respectively. Did Health Canada grant full indication extrapolation to Celltrion’s biosimilar infliximab?

  • Major events in Q2 2014 included biosimilar developers leveraging the conference season to present biosimilar data to a physician-targeted audience. The FDA published draft guidance on clinical pharmacology for biosimilars. Are there any points of harmonization between the FDA and EMA?

  • Major events in Q3 2014 included several regulatory “firsts” with the FDA accepting the first 351(k) biosimilar application and both the FDA and the EMA approving the first biosimilar insulin glargine developed by Eli Lilly and Boehringer Ingelheim. What is the commercial implication of these approvals?

  • Major events in Q4 2014 focused on non-G7 markets with further global development of abbreviated biosimilar pathways. In China, draft biosimilar guidance was made available for consultation, while a biosimilar pathway was established in Russia. What factors have driven the development of these pathways? Who stands to benefit?

  • 2015 is expected to be a landmark year for biosimilars with multiple biosimilar product launches and rapidly advancing biosimilar development pipelines. Which products in the biosimilars pipeline are expected to launch in 2015?


Markets covered: Global.

Primary research: Insights from 548 surveyed experts: U.S. and European oncologists (n = 182); U.S. and European nephrologists (n = 90); U.S. and European gastroenterologists (n = 95); U.S. and European rheumatologists (n = 89); U.S. and European endocrinologists (n = 92).

Author(s): Anees Malik, M.Pharm, M.Phil.