Year in Review: Top 5 Foreign Market Developments in 2017

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017:

  1. The European, Latin American, and Asian markets are thriving with biosimilar applications and approvals.  For example, a rituximab biosimilar was approved in Latin America.  The EMA issued marketing approvals for at least rituximab (e.g., link), etanercept, (e.g., link),  and adalimumab biosimilars (e.g., link, link), with numerous biosimilar applications for adalimumab, infliximab, insulin glargine, pegfilgrastim, and trastuzumab pending review (e.g., link, link).  In India, both Intas and Biocon launched a bevacizumab biosimilar for the treatment of metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian, and brain cancers.
  1. Many deals have closed to promote the research and development of biosimilar products.  For example, Fresenius Kabi announced that it aquired Merck KGaA’s biosimilars business, which comprises Merck’s entire biosimilars development pipeline.  Also, Aurobindo Pharma Limited acquired four biosimilar products from TL Biopharmaceutical AG.
  1. Regulatory and competition agencies are actively policing the biosimilar industry.  For example, the EMA issued a statement of non-compliance after an inspection of Biocon’s Bengaluru product plant showed that Biocon was not complying with Good Manufacturing Practice protocols.  Additionally, the UK’s Competition and Markets Authority (CMA) provisionally determined that Merck Sharp & Dohme (MSD) violated competition law with its discount pricing on Remicade.
  1. The World Health Organization launched a pilot project for prequalifying biosimilar medicines in an effort to expand access to biosimilar treatments in low- and middle-income countries.  Under the program, once a product is prequalified by WHO, the product would be eligible for procurement by United Nations agencies.
  1. President Trump formally abandoned the TPP.  One of the most contentious issues in the TPP was the data exclusivity period that member states must provide for biologics.  While the U.S.’s BPCIA provides for 12-years of data exclusivity, some TPP-member countries provide much less (e.g., Australia provides for 5 years of data exclusivity).  The TPP provided a compromise under which biologics data would be protected for at least five years.