Biosimilars Key CompetitorsTrial and Approval Timelines MerckBlueocean estimates
Biosimilars Key Competitors—Trial and Approval Timelines* *Merck-Blueocean estimates Amgen: First in the US; biosimilars likely to launch both in emerging markets and the US 2013 Q 1 Q 2 2014 Q 3 Q 4 Mature markets NSCLC N=620 Q 1 Q 2 Q 3 2015 Q 4 Q 1 Q 2 Q 3 2016 Q 4 Q 1 Q 2 Q 3 2017 Q 4 Q 1 Phase 3 trial duration (Nov 2013 -Sep 2015) Phase 1 trial (completed) Healthy volunteers (Feb 2014 -Aug 2014) N=102 Q 2 US NSCLC N=660 Phase 3 trial duration (Jun 2015 -May 2017) NSCLC N=798 Phase 3 trial duration (Apr 2015 -Jul 2017) 2019 2018 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Lo. E Jul 2019 EU US EU Enrollment initiation by Apr’ 15 US EU Phase 1 initiated in Q 4’ 14 / Q 1’ 15 in UK Emerging markets Phase 1 in healthy male volunteers in Q 3’ 13 in UK NSCLC N=214 Current status of GP 2019 not known Phase 3 trial duration (Oct 2012 -Nov 2015) CRC N=140 Russia Phase 3 trial duration (Aug 2014 -Aug 2015) CRC N=146 EM Phase 3 trial duration (Nov 2014 -Nov 2015) India Key competitors with bevacizumab biosimilars in preclinical research phase (Market entry—Post 2020) CT-P 16 (for colon cancer) 1 • • Bevacizumab biosimilar GBS-004 in Japan (for oncology) Bevacizumab biosimilar (for CRC and NSCLC) The approval estimates are the earliest possible dates based on the ongoing clinical development programs for the biosimilars The launch dates would be dependent on data exclusivity, relevant patent expiries, and patent litigations Sources are provided in the Notes section Lo. E Jul 2020
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