Strategic Vision: A Global Pharma Company
Progress on Biosimilar Pipeline
LUPIN
Molecule
Reference
Product
Clone & Process
Development
Pre-
Clinical
Phase I
Phase III
Filing in
US/EU/JP
US/EU/JP Approval
Etanercept
EnbrelⓇ
Neulasta® (PFS &
Pegfilgrastim
Onpro)
Ranibizumab
LucentisⓇ
Aflibercept
Eylea®
Denosumab
Xgeva®, Prolia®
Pertuzumab
PerjetaⓇ
Lupin0019
& Launch
Launched in JP/EU/India/Thailand
Filed: Canada/Australia and several other
Emerging Markets
US BLA Under review by FDA and several other markets.
Launched in India. On-body-injector clinical trial ongoing.
Global Phase III (US/EU/India) ongoing. India MAA received and Launch
preparation ongoing
Toxicology studies complete. IND in preparation. Phase III to be initiated shortly
Toxicology studies complete.
Toxicology studies complete.
Clone Ready and Process finalization ongoing.
1. IQVIA MAT Mar 2022
Total Biosimilar target market size of ~US$ 36 bn¹
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