Investor Presentation
Biosimilar pipeline (status as of October 2023)
Targeted
brand
HumiraⓇ (adalimumab)³
Therapeutic
areas
Immunology
Originator net
sales targeted
~USD 21bn¹
Source
In-house
Polpharma Biologics
Samsung Bioepis
Bio-Thera Solutions
Current
status
Launched in US July 2023
EU launch expected H2 2023
Approved US August 2023
File accepted in EU in July 2022
File accepted in US February 2023
and EU May 2023
Positive Phase III results August 2023
Phase III completed in November
2022
File Accepted in US December 2021
and EU January 2022
File Accepted in US January 2021 and
EU November 2020
File Accepted in US February 2023
and EU in August 2023
File Accepted in US in June 2023
TysabriⓇ (natalizumab)
Neurology/
~USD 2bn¹
Immunology
ProliaⓇ/XgevaⓇ (denosumab)
Bone diseases /
~USD 7bn1
In-house
Oncology
Eylea® (aflibercept)
Ophthalmology
~USD 11bn¹
In-house
StelaraⓇ (ustekinumab)
Immunology
~USD 10.3bn²
HerceptinⓇ (trastuzumab)
Oncology
~USD 1.8bn²
EirGenix
AvastinⓇ (bevacizumab)
Oncololgy
~USD 1.7bn²
LantusⓇ (glargine)
Diabetes
~USD 2bn²
Gan & Lee
HumalogⓇ (lispro)
NovoLogⓇ (aspart)
Diabetes
Diabetes
~USD 1.8bn²
~USD 4bn²
Gan & Lee
Gan & Lee
15 other undisclosed compounds
File Accepted in US in June 2023
Note: Status as of September 2023; the third-party trademarks above are property of their respective owners, 1. Originator sale covered based on Company analysis using Evaluate Pharma; at full year prior to expected market formation year,
Originator sales from Evaluate Pharma for 2023 since all of these molecules are post LOE, 3. Only pertains to adalimumab high concentration formulation (HCF)
2.
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Management Presentation
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