Wednesday, September 17, 2014

Biosimilars in immunology...the march continues...Plus coverage of European Gastroenterology Week

Epirus' Remicade biosimilar, BOW015 has received final approval in India [link]
  • This marks the first infliximab biosimilar to be approved in India
  • Ranbaxy and Epirus signed a licensing agreement for BOW015 in January 2014. Under the terms of the agreement, Epirus was to develop and supply BOW015, while Ranbaxy was to register and commercialize BOW015 in India 
  • BOW015 will be manufactured by Reliance Life Sciences in Mumbai and launched as Infimab by Q1 2015
  • We understand that the Indian market for Remicade is worth $8-10M/year
  • Epirus reported Phase 3 data for BOW-015 in RA patients at EULAR 2014.  In addition to supporting approval in India, Epirus has commented that it intends to leverage clinical data to support additional regulatory filings in targeted global markets
  • Ranbaxy aims to launch in other territories in Southeast Asia, North Africa, and selected other markets, while Epirus has previously announced an agreement with Brazilian companies Orygen, Eurofarma and Biolab to support filing in Brazil
  • Epirus has commented that it plans to initiate an additional Phase 3 trial in Europe in early 2015
For a detailed look into what's new in the world of biosimilars ask about our UpdatesPlus service.  This dedicated service provides regular monitoring and analysis of immunology therapy areas.

Special announcement: Attendance of UEG Week (October, 2014)
UEG is the largest gastroenterology meeting in Europe attracting around 14,000 participants.  If you are already active in IBD drug development, or if you are considering expanding into this therapy area, we are offering cost-effective coverage of the meeting.  If you are interested in receiving coverage of the meeting please let us know by the end of this week.  As part of our coverage we would provide the following
  • Pre-conference planner with an analysis of what can be expected from key data releases
  • Post conference report
  • Analysis of key posters and oral presentations
  • Update on any new therapeutic candidates approaching the clinic as well as new data on current candidates
  • KOL opinion - at the moment key issues will probably be around early Entyvio uptake; attitudes to biosimilar attitudes; opinion around new tailored dosing regimens.  Really however, this is your opportunity to ask us to address any burning questions you may have

To date interest in UEG has been high as by sharing the cost we are able to cover the meeting for a fraction of what is otherwise possible.  So if you are unable to attend but want to know what is to be presented, or if you already have coverage but want a very cost-effective extra pair of eyes and ears please let us know


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