Evolving Biosimilars Landscape: Opportunities and Challenges

May’s program was held at The Nippon Club. To download the event flyer, click here.

Key Players and Pipelines , the Advance of Biosimilars in Korea, and the State of Biosimilars in Japan

Sponsored by Ropes & Gray LLP

(click here for speaker bios)

  • Hiroyuki Kawabata, Director of Health & Welfare Dept., JETRO New York
  • Tae-Wan Kim, PhD, Assoc. Professor of Pathology and Cell Biology, Columbia University School of Medicine
  • Hassen Sayeed, MDPartner, Ropes & Gray LLP
  • Robert RouseSenior Principal, IMS Consulting Group
  • Paul VillaSenior Principal, IMS Consulting Group

After years of anticipation, on March 6th the FDA approved a biosimilar product for the first time, Sandoz’s Zarxio. While biosimilars have been on the market in Europe for 10 years, the U.S. is just entering this market, which represents a new era for the biopharma industry that will bring both opportunities and challenges. According to a Frost & Sullivan research report last year, the global biosimilars market had revenues of approximately $1.2 billion in 2013, but could reach $24 billion in 2019. Approximately $60 billion worth of the industry’s biggest blockbuster biologics are coming off patent in the U.S. and Europe in the next several years, which opens the door for a lot of biosimilar product opportunities. Another factor contributing to the potential growth of the biosimilars market is the continued rise in chronic diseases, which drives the need for more cost-effective healthcare.

At this program, four experts will discuss the current regulatory, business and commercial environment for biosimilars. Their presentations will include:

  • Overview on the biosimilars market and environment, key players and pipelines
  • The current regulatory guidelines and patent issues
  • Case studies from Korea: how Korean government and industry advanced biosimilars in Korea and the global market
  • Where the Japanese regulatory agency, the Ministry of Health and Welfare, stands with biosimilars in Japan