Dr. Fermin Ruiz de Erenchun (Head Biologic Strategy Team) Dr. Bruno Eschli (IR Officer) 8th Annual Biosimilar Conference / Bernstein; December 2015
Recent developments and global trends in the
biosimilar market: What would oncology look like?
2
Biosimilar: Ten years on the making
Roche’s Strategy: Innovate, Protect, Expand
Portfolio outlook
HER2 franchise
CD20 franchise
Avastin franchise
Biosimilars: Ten years in the making
3
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
EU pioneered the biosimilar
concept
– Six products approved, including the first mAb biosimilar (infliximab)
– Uptake did not achieve
saving expectations
WHO leading global efforts; many emerging countries implemented WHO biosimilar guidelines as a reference
US published final biosimilars guideline
– FDA pathway operating, 7 applications pending, one approval
Biosimilar entry timelines delayed (incl. Herceptin & MabThera)
Differential adoption of WHO biosimilar guidelines led to registration of Non-Comparable Biotherapeutic products (NCBs)*, driven by:
– Capacity issues at National
Regulatory Agencies
– Local economic development policies
*For definition and industry position on NCBs please refer to IFPMA Policy Statement:
http://www.ifpma.org/uploads/media/Non-comparable_Biotherapeutic_Products__English__01.pdfr
0.6 6.3
57.0
80 95
119
219
267
317
254
315
377
0
50
100
150
200
250
300
350
400
MAT Jun 2013 MAT Jun 2014 MAT Jun 2015
Sa
les in
CH
Fm
Infliximab
Somatropin
Filgrastim
Epo
Current biosimilar trends
So far, sales have not achieved initial expectations
4
MAT 870 CHFm (June 2015) (CAGR 25.5%)
*Excludes US as no biosimilars have been approved in the US so far (Omnitrope was approved under the 505(b) pathway)
IMS Health; MAT=moving annual total
Generics versus biosimilars
Clear divide in uptake; complex market drivers
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
5
Market share
Zyprexa (Eli Lilly)
Diovan (Novartis)
Filgrastim
EPO
Somatropin
Small molecule
Virtually disappear
Payer driven: 7 biosimilars
Efficacy visible immediately
High turnover of patients
Driven by price and patient offering
9 innovators, one biosimilar
Efficacy visible only longer term
No switching
Sources: IMS Biosimilar Dashboard, IMS & Roche analysis 1 Volume market share based on EU5 average; 2 Volume market share based on average of France & Germany EPO; 3 Data based on % remaining sales in EU
1
1
2
3
3
Anti-TNF antibody market is not a good
analogue for oncology
7
Anti TNF
Other
biologics
IV Anti-TNF
SC
Anti-TNF
Biological
products used
to treat RA, IDB
& Psoriasis
Infliximab biosimilar could expand beyond it’s accessible market and obtain market
share from Enbrel® and Humira®
Remicade®
Biosimilar accessible market
Consolidation of biosimilar companies and shift to ‘Big Pharma’
8
• New players are ‘Big Pharma’
companies with fully developed
vertical capabilities
• Brand sales model as the most
likely go-to-market scenario
• Integration (Pfizer & Hospira) or
partnerships with generic
companies or CMOs provide
portfolio synergies and
comprehensive commercial
capabilities
Emerging trends
9
Biosimilar: Ten years on the making
Roche’s Strategy: Innovate, Protect, Expand
Portfolio outlook
HER2 franchise
CD20 franchise
Avastin franchise
Roche strategy is aligned with our business model
10
Protect high standards
Enforce efficacy and safety standards, defend intellectual property
Act to expand patient access in emerging markets
Change from global pricing to tiered pricing, including 2nd brand
Protect
Re-define the standard of care
Mode of administration, combination therapies and new drugs Innovate
Expand
Herceptin
More than 27,000 women in Western Europe did not develop metastatic disease
11 Weisgerber-Kriegl, U. et al. Estimation of the epidemiological effect of trastuzumab over 10 years in 5 European Countries. J. Clin. Onco., 2008.
ASCO Annual Meeting Proceedings: 26:15S
Incidence of HER2-positive MBC without Herceptin Number of women prevented from developing metastases
Num
ber
of
patients
27,737
20,000 Herceptin introduced
in adjuvant setting
Year
18,000
16,000
14,000
12,000
10,000
8000
6000
4000
2000
0
2000 2005 2010 2015
Innovate
Biosimilar pathways
in place
Biosimilar pathways
under development
2010 2015
Establishment of biosimilar guidelines has
increased driven by WHO efforts
12
Protect
Requirements and study designs are different
for the biosimilar versus innovator
13 * In some cases SoC may not exist; PD=pharmaco dynamics; OS=overall survival; PFS=progression free survival
Aspects of development Biosimilar Innovator
Patient population Sensitive and homogeneous
(patients are models)
Any
Clinical design Comparative versus innovator,
normally equivalence
Superiority vs standard of care
(SoC*)
Study endpoints Sensitive, clinically validated PD
markers
Clinical outcomes data or
accepted/established
surrogates (e.g. OS and PFS)
Safety Similar safety profile to
innovator; no new findings
Acceptable benefit/risk profile
versus SoC*
Immunogenicity Similar immunogenicity profile to
innovator
Acceptable risk/benefit profile
versus SoC*
Extrapolation Possible if justified Not allowed
Protect
How should extrapolation risk be managed?
The regulator’s perspective
Analytical
Non-clinical
Clinical
14
Protect
How should extrapolation risk be managed?
The physician’s perspective
Analytical
Non-clinical
Clinical
Analytical
Clinical
Non-clinical
I would like to
see a phase III
trial for each
indication
15
Protect
Phase III clinical trials will be required for
biosimilar antibodies
16 PD=pharmaco dynamics; Source: CHMP Assessment report for Zarzio, page 20; EMA/CHMP/651339/2008
PD markers only suitable for some products
Protect
What is the right patient population to establish
clinical similarity to Herceptin?
17
Topic mBC
Advanced metastatic population
eBC
Neoadjuvant/adjuvant population
PK Affected by patients status & tumor
burden
Homogeneous population can be
selected
PD Clinically validated PD marker not available
Clinical
efficacy/safety • Difficult to select homogeneous group.
• Need to control and stratify for multiple
factors (e.g. prior use of chemotherapy,
performance status…).
• Population with heterogeneous
characteristics affecting final clinical
outcome.
Populations less likely to be confounded by
baseline characteristics and external
factors
Immunogenicity Immune system affected by performance
status and concomitant chemotherapies
received
Immune system impaired during
chemotherapy cycles, but likely to
recover to normal status thereafter
Protect
mBC=metastatic breast cancer; eBC=early breast cancer; PK=pharmaco kinetics; PD=pharmaco dynamics
mBC Phase III Start
Regulatory
Filing eBC
Phase III Start
Celltrion Q2 2010 Q1 2014
Mylan Q4 2012
Pfizer Q4 2013 Q2 2014
Samsung Q2 2014
Amgen Q4 2013
The regulatory thinking is evolving
The Herceptin case
Pfizer
Samsung
2011 2012 2013 2014 2010
mBC
eBC
Initiation of
clinical trial
Celltrion Mylan Pfizer
Celltrion
Amgen
Protect
mBC=metastatic breast cancer; eBC=early breast cancer
Innovative approaches to improve market access
19
Established markets
Environment increasingly complex
Payers more active/influential
Emerging markets
Build-up of healthcare systems,
but applying stricter cost regulations already
Expand
20
Biosimilar: Ten years on the making
Roche’s Strategy: Innovate, Protect, Expand
Portfolio outlook
HER2 franchise
CD20 franchise
Avastin franchise
Positive outlook provided at Investor Day 2015
Strong pipeline mitigates biosimilar impact
2014 2015E 2016E 2017E 2018E 2019E 2020E 2021E 2022E 2023E
Marketed
products
Sales
Pipeline
Biosimilars
MabThera, Herceptin, Avastin
NME launches
Venetoclax, Alectinib, Cotellic, Ocrelizumab, Atezolizumab,
Lebrikizumab, ACE910, Lampalizumab
21 NME=new molecular entities
Multiple major pivotal trials reading out near term
Significant filing and launch activities ahead
22
Year Molecule Indication Market
opportunity
Incremental
infrastructure
2015
Alectinib ALK+ NSCLC Low to medium
Cotellic/Zelboraf Melanoma Low
Venetoclax Hematology (CLL 17p del) Low
2016
Ocrelizumab Multiple Scelerosis Medium
Atezolizumab NSCLC, bladder (2/3L) Medium
Lebrikizumab Asthma, AD, IPF, COPD Large
APHINITY Adj HER2+ breast cancer Low
GOYA NHL (aggressive) Low
2017
ACE 910 Hemophilia A Low to medium
Lampalizumab Geographic atrophy Low to medium
GALLIUM NHL (indolent) Low
Atezolizumab+chemo NSCLC (1L) Low
Post
2017
Taselisib (PI3Ki) HER2-/HR+ breast cancer Low to medium
Idasanutlin (MDM2) Acute myeloid leukemia Low to medium
Oncology Neuroscience Ophthalmology Immunology
Small: up to CHF 0.5 bn medium= CHF 0.5 to CHF 1bn large > CHF1bn
NSCLC=non-small cell lung cancer; CLL=chronic lymphocytic leukemia; AD=atopic dermatitis; IPF=idiopathic pulmonary fibrosis; COPD=chronic obstructive pulmonary disease; NHL=non-Hodgkin’s lymphoma; Venetoclax in collaboration with AbbVie
Multiple major pivotal trials reading out near term
Several read-outs to protect established franchises
23
Year Molecule Indication Market
opportunity
Incremental
infrastructure
2015
Alectinib ALK+ NSCLC Low to medium
Cotellic/Zelboraf Melanoma Low
Venetoclax Hematology (CLL 17p del) Low
2016
Ocrelizumab Multiple Scelerosis Medium
Atezolizumab NSCLC, bladder (2/3L) Medium
Lebrikizumab Asthma, AD, IPF, COPD Large
APHINITY Adj HER2+ breast cancer Low
GOYA NHL (aggressive) Low
2017
ACE 910 Hemophilia A Low to medium
Lampalizumab Geographic atrophy Low to medium
GALLIUM NHL (indolent) Low
Atezolizumab+chemo NSCLC (1L) Low
Post
2017
Taselisib (PI3Ki) HER2-/HR+ breast cancer Low to medium
Idasanutlin (MDM2) Acute myeloid leukemia Low to medium
Oncology Neuroscience Ophthalmology Immunology
Small: up to CHF 0.5 bn medium= CHF 0.5 to CHF 1bn large > CHF1bn
NSCLC=non-small cell lung cancer; CLL=chronic lymphocytic leukemia; AD=atopic dermatitis; IPF=idiopathic pulmonary fibrosis; COPD=chronic obstructive pulmonary disease; NHL=non-Hodgkin’s lymphoma; Venetoclax in collaboration with AbbVie
Franchise strategies for long term growth
New indications, longer duration and SC conversion
24
Growth
opportunity Indication
Global peak
sales potential
HER2 franchise
Perjeta adjuvant (APHINITY)
Herceptin SC*
CD20 franchise
Gazyva aNHL (GOYA)
Gazyva iNHL (GALLIUM)
Venetoclax
MabThera SC*
Small: up to CHF 0.5 bn medium= CHF 0.5 to CHF 1bn large > CHF1bn
*Sales replacing current intravenous products; SC=subcutaneous; iNHL=indolent non-hodgkin’s lymphoma; aNHL=aggressive NHL
25
Biosimilar: Ten years on the making
Roche’s Strategy: Innovate, Protect, Expand
Portfolio outlook
HER2 franchise
CD20 franchise
Avastin franchise
HER2 franchise
Strengthening standard of care
26
Established SoC Potentially new SoC New trials
Adjuvant BC Herceptin +
chemo
Herceptin SC+ chemo
(HannaH)
Herceptin & Perjeta + chemo (APHINITY)
1st line mBC Herceptin
+ chemo Herceptin & Perjeta + chemo (CLEOPATRA)
2nd line mBC Xeloda + lapatinib Kadcyla (EMILIA)
2017 2016 2012 2013 2014 2015 2011 2019 2018
Est. Biosimilars
launch (EU)
Neoadjuvant BC Herceptin + chemo
(NOAH)1 Herceptin & Perjeta + chemo
(Neosphere, Tryphaena)2
Kadcyla & Perjeta + chemo (KRISTINE)
atezolizumab + Herceptin + Perjeta
atezolizumab + Kadcyla
Ma
rke
t
(Pro
duct
launches)
P
ipe
lin
e
(Tri
al st
art
s)
eBC/mBC
eBC/mBC
atezolizumab (aPD-L1 MAb); mBC=metastatic breast cancer; eBC=early breast cancer; SC=subcutaneous; SoC=standard of care
HR=0.76 (95% CI: 0.67-0.86)
% E
ve
nt
-Fre
e
60
40
20
0
0 2 4 6 8 10
P<0.0001
0 1 2 3 4 5
P=0.016
100
80
28.8% 41.9%
% E
ve
nt
-Fre
e
60
40
20
0
100
80
HR=0.64 (95% CI: 0.44-0.93)
Without Herceptin With Herceptin
Years from Randomization1
HER2 positive eBC: Still high medical need
despite major advances
27
Years from Randomization2
Neoadjuvant - NOAH trial Adjuvant - HERA trial
Disease-Free Survival Event-Free Survival
1 Roche data on file; 2 L. Gianni et al, ASCO Annual Meeting 2013
eBC=early breast cancer
HER2 franchise: Significant growth opportunities
in approved indications remain
• Increased patient share
• Longer treatment duration
• Emerging markets
28
96%
84%
63% 58%
93%
<5%
51%
58%
25%
<5%. <5% <5% 0%
100%
Herceptin Perjeta 1L Perjeta 2L Kadcyla
mBC
Pa
tie
nt
sh
are
s
Sources: Market research tracking studies - Latest quarter Q315 in EU5 and US; mBC=metastatic breast cancer
US
EU5
EM
Neoadjuvant Adjuvant
Herceptin SC
Conversion rate exceeds 35% after two years
29
SC share of Herceptin sales in
launched countries
0%
5%
10%
15%
20%
25%
30%
35%
40%
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Sa
les m
ark
et
sh
are
(%
)
Number of countries where
Herceptin SC has been launched
0
10
20
30
40
50
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
To
tal
nu
mb
er
of
co
un
trie
s
SC=subcutaneous
30
Biosimilar: Ten years on the making
Roche’s Strategy: Innovate, Protect, Expand
Portfolio outlook
HER2 franchise
CD20 franchise
Avastin franchise
CD20 franchise
Strategy for long term growth
31
MabThera
MabThera
SC
Gazyva
Gazyva Protect
Replace
Protect.. Replace.. Extend..
MabThera
Venetoclax
Polatuzumab
Atezolizumab aCD20/CD3 TCB
Gazyva
Me
dic
al
va
lue
MabThera
SC
• Await GOYA and GALLIUM
• Extend Gazyva with GREEN
• Rapidly and sustainably
convert the market to SC
• Increase medical benefit with Venetoclax in
NHL, CLL and expand into new diseases e.g.
Multiple Myeloma
• Additional NMEs in the clinic
SC=subcutaneous; CLL=chronic lymphocytic leukemia; NHL=non-hodgkin’s lymphoma; TCB=T cell bispecific;
NMEs=new molecular entities; Venetoclax in collaboration with AbbVie
Multiple approaches to protect MabThera sales
1L CLL Typical
5%
1L CLL Fit
6%
CLL 17p-del
1%
R/R CLL
5%
1L aNHL
27%
R/R aNHL
6%
iNHL
49%
GAZYVA (GOYA) in aNHL
(improve > SoC)
Gazyva (GALLIUM)
(improve > SoC)
Gazyva (GREEN)- Extend
chemo backbone
Venetoclax –
Extend efficacy
Rapidly and sustainably
convert market to SC
Broad development program for venetoclax as add on and in new tumour types
32
Rapidly and sustainably
convert market to SC
SoC=standard of care; SC=subcutaneous; CLL=chronic lymphocytic leukemia; iNHL=indolent non-hodgkin’s lymphoma; aNHL=aggressive NHL; R/R=relapsed/refractory
MabThera SC
NHL launch ongoing, strong uptake in most markets
33
• First EU launches in 2014, ongoing or imminent in further countries
• Encouraging initial uptake in majority of markets, comparable to Herceptin SC
• Slower conversion in countries with strong incentives to use IV (Germany) or
limited reimbursement (UK)
SC=subcutaneous; IV=intravenous
34
Development plan hematology franchise I
8 NMEs in the clinic Compound Combination Study name Indication P 1 P 2 P 3
Gazyva +bendamustine GADOLIN iNHL (Rituxan refractory)
Gazyva +CHOP GOYA aNHL
Gazyva +chemo GALLIUM 1L iNHL
Gazyva +FC/bendamustin/Clb GREEN CLL and R/R CLL
venetoclax* +Rituxan/+Rituxan+bendamustine CONTRALTO R/R FL (iNHL)
venetoclax +Rituxan+CHOP/Gazyva+CHOP CAVALLI 1L aNHL
venetoclax +Rituxan+bendamustine R/R NHL
venetoclax R/R CLL and R/R NHL
venetoclax +Rituxan R/R CLL and SLL
venetoclax +Gazyva CLL14 CLL
venetoclax +Rituxan MURANO R/R CLL
venetoclax R/R CLL 17p
venetoclax R/R CLL after ibru/idel
venetoclax +Rituxan+bendamustine R/R CLL and CLL
venetoclax +Gazyva R/R CLL and CLL
venetoclax R/R MM
venetoclax +bortezomib+dexamethasone R/R MM
venetoclax AML
venetoclax +decitabine/+azacitidine/+LdAraC AML
venetoclax (Bcl2 inhibitor); NME=new molecular entity; iNHL=indolent non-hodgkin`s lymphoma; aNHL=agressive NHL; CLL=chronic lymphoid
leukemia; R/R CLL=relapsed/refractory CLL; MM=multiple myeloma; AML=acute myeloid leukemia; CHOP=cyclophosphamide, doxorubicin,
vincristine and prednisone; FC=fludarabine, cyclophosphamide; LdAraC=low dose cytarabine; * venetoclax in collaboration with AbbVie
Ph1 Ph2 Ph3
NHL
AML
MM
CLL
CLL
NHL
= filed
35
Development plan hematology franchise II
8 NMEs in the clinic
Compound Combination Study name Indication P 1 P 2 P 3
polatuzumab* +Rituxan/Gazyva ROMULUS R/R FL and aNHL
polatuzumab +Gazyva+benda/Rituxan+benda R/R FL (iNHL) and aNHL
polatuzumab +Gazyva+CHP/Rituxan+CHP 1L aNHL
polatuzumab +Gazyva+lenalidomide R/R FL and aNHL Q4
polatuzumab +Gazyva+venetoclax R/R FL and aNHL Q4
undisclosed ADC R/R NHL
atezolizumab +Gazyva R/R FL (iNHL) and aNHL
atezolizumab +Gazyva+lenalidomide R/R FL and aNHL Q4
atezolizumab +CHOP aNHL Q4
atozolizumab +bendamustine R/R FL and aNHL Q4
atezolizumab +Gazyva+polatuzumab R/R FL and aNHL Q1
atezolizumab +lenalidomide MM
atezoliozumab +azacitidine MDS
aCD20/CD3 TCB Heme tumors
LSD1 inhibitor** AML
idasanutlin Heme tumors
Ph1 Ph2 Ph3
AML
NHL
MM
NHL
MDS
NHL
polatuzumab vedotin (aCD79b ADC); atezolizumab (aPD-L1 MAb); aCD20/CD3 TCB (RG7828); LSD1 inhibitor (RG6016); idasanutlin (MDM2 antagonist);
iNHL=indolent non-hodgkin`s lymphoma; R/R FL=relapsed/refractory follicular lymphoma; aNHL=agressive NHL (DLBCL); MM=multiple myeloma;
MDS=myelodysplastic syndrom; AML=acute myeloid leukemia; *in collaboration with Seattle Genetics; ** in collaboration with Oryzon Genomics
= additional trials starting in Q4 15 and Q1 16
Gazyva and venetoclax read-outs in CLL
36
Venetoclax1 R-
Venetoclax8
Gazyva-
bendamustine7
Gazyva-
chlorambucil2 R-chlorambucil2 R-FC3 Ibrutinib4 Idelalisib5 R-Benda-
Ibrutinib6
Line R/R R/R 1L 1L 1L 1L 1L R/R R/R R/R
N 78 49 158 238 233 408 31 61 54 30
ORR 77% 86% 78.5% 75.5% 65.9% 90% 71% 67% 56% 90%
CR/CRi 23% CR/CRi 41% CR/CRi 32.3% 22.2%
CR/CRi
8.3%
CR/CRi 44% 10 % 3% 4% 10%
MRD-
negative
BM: 55%
(6/11)*
BM: 75%
(15/20)
53% (ITT)
PB: 58.9%
BM: 27.8%
(ITT)
PB: 31% (41/132)
BM: 17% (15/88)
PB: 2% (3/150)
BM: 3% (2/72)
PB: 63%
(90/143) Not reported
Not
reported
Not
reported
CLL=chronic lymphoid leukemia; R=Rituxan; FC=fludarabine; R/R=relapsed/refractory; 1L=first-line; ORR=overall response rate; CR=complete response; CRi=complete response with incomplete bone marrow recovery; MRD=minimal residual disease; BM=bone marrow; PB=peripheral blood *MRD tests performed in local unvalidated laboratories in a small number of patients; in patients with a CR who have been tested
References:
1. John Seymour, EHA 2014
2. Goede et al. J Clin Oncol 2013; 31:suppl; abstr 7004 (presentation update)
3. Böttcher et al. J Clin Oncol 2012 ;30:980-988
4. Byrd et al. Blood (ASH Annual Meeting Abstracts) 2012 120: Abstract 189
5. Flinn et al. Hematol Oncol 2013; 31 (Suppl. 1): Abstract 297
6. Brown et al. Haematologica 2012; 97(s1) : Abstract 0543
7. Stilgenbauer et al., ASH 2015 (GREEN subgroup analysis)
8. Ma Shuo et al., ASH 2015 (abstract 80273)
37
Biosimilar: Ten years on the making
Roche’s Strategy: Innovate, Protect, Expand
Portfolio outlook
HER2 franchise
CD20 franchise
Avastin franchise
Cancer immunotherapy (CIT): 8 NMEs in the clinic
38
T cell infiltration
T cell Trafficking
Cancer T cell recognition
anti-CEA/CD3 TCB
anti-CD20/CD3 TCB
anti-HER2/CD3 TCB
ImmTAC* (Immunocore)
anti-VEGF (Avastin)
Clinical development CIT Preclinical development CIT
* Partnered projects (external)
Established therapies outside CIT
Chen and Mellman. Immunity 2013
T cell killing
anti-PDL1 (atezolizumab)
anti-CSF-1R
IDOi (NewLink)
IDOi* (Incyte)
CPI-444* (Corvus)
anti-TIGIT
IDOi/TDOi* (Curadev)
EGFRi (Tarceva)
ALKi (Alectinib)
BRAFi (Zelboraf)
MEKi (Cotellic)
anti-CD20 (Gazyva)
anti-HER2 (Herceptin; Kadcyla; Perjeta)
various chemotherapies
lenalidomide
rociletinib* (Clovis)
Antigen presentation
anti-CD40
CMB305 vaccine* (Immune Design)
T-Vec oncolytic viruses* (Amgen)
Priming & activation
anti-CEA-IL2v FP
anti-OX40
anti-CD27* (Celldex)
entinostat* (Syndax)
anti-FAP-IL2v FP
Antigen release
• anti-Ang2/VEGF biMAb
(vanucizumab) has entered
phase II testing in mCRC
39
Setting new standards, developing combinations
venetoclax
alectinib Cotellic
aCSF-1R
aCEA-IL2v FP
aOX40
aCD40
IDO
aCEA/CD3 TCB
Launched portfolio
Immunotherapy portfolio
chemo
Targeted combinations approved
Chemotherapy combinations approved
CIT combinations in trials
CIT Chemotherapy combinations in trials
NMEs filed/recently approved
aCD20/CD3 TCB atezolizumab
40
Setting new standards, developing combinations
Building on established backbones
venetoclax
alectinib Cotellic
aCSF-1R
aCEA-IL2v FP
aOX40
aCD40
IDO
aCEA/CD3 TCB
chemo
Targeted combinations approved
Chemotherapy combinations approved
Roche combinations in trials
Chemotherapy combinations in trials
NMEs filed/recently approved
aCD20/CD3 TCB atezolizumab
CD20 franchise
HER2 franchise
Avastin franchise
Avastin+atezolizumab combos entered Ph3
41
Phase III Phase I atezo
2/3L NSCLC
atezo
2/3L Bladder
atezo+Avastin+chemo
1L non sq NSCLC
atezo+chemo
1L non sq NSCLC
atezo+chemo
1L sq NSCLC
atezo
1L non sq NSCLC (Dx+)
atezo
1L sq NSCLC (Dx+)
atezo+chemo
1L TNBC
atezo
Adjuvant MIBC (Dx+)
atezo
Adjuvant NSCLC (Dx+)
atezo+Avastin
1L RCC
Status as of Nov 5, 2015
atezo
NSCLC (Dx+)
atezo
2/3L NSCLC
atezo+Avastin
1L Renal
atezo
1/2L Bladder
Phase II
IDO
Solid tumors
atezo+ipilimumab
Solid tumors
atezo+aCD40
Solid tumors
atezo+IFN-alfa
Solid tumors
atezo+aCSF-1R
Solid tumors
atezo+aCEA-IL2v FP
Solid tumors
atezo+aOX40
Solid tumors
atezo+IDO
Solid tumors
atezo+Zelboraf
Melanoma
atezo+Tarceva
NSCLC
atezo+Avastin+chemo
Solid tumors
atezo+Gazyva
R/R FL / aNHL
aCD20/CD3 TCB
heme tumors
atezo+Avastin
Solid tumors
atezo+Cotellic
Solid tumors
atezo+Zelboraf+Cotellic
Melanoma
atezo+lenalidomide
MM
atezo+chemo
Solid tumors
atezo
Solid tumors
aCSF-1R
Solid tumors
aOX40
Solid tumors
aCEA/CD3 TCB
Solid tumors
aCEA-IL2v FP
Solid tumors
atezo+alectinib
ALK+ NSCLC
atezo+/-azacitidine
MDS
atezo+Gazyva+chemo
R/R FL/aNHL
atezo+Kadcyla
HER2+ eBC/mBC
atezo+Herceptin+Perjeta
HER2+ eBC/mBC
atezo+Gazyva+lenalidomide
R/R FL/aNHL
atezolizumab trials
NME monotherapy
Immune doublets
Combinations with
Avastin, Herceptin,
Kadcyla, Gazyva
Combination pricing in oncology
(+)
– Addresses the reality of
combination treatments,
particularly oncology
– Takes healthcare budget into
consideration
(-)
– Not all drug combos are
from the same company
– High complexity with many
possible combinations
“Ensures benefits of combination therapies are reflected while considering the
limits of healthcare budgets”
Now – unit of drug has same price, whether used as single agent or
in combination
Future – price varies by single or combination use based on benefit
Single use or combination List price product A
(invoice price)
Price X
Price Y Product B
Product A + B
Product A
Product A + B Price Z
List price product B
(invoice price)
Price X+Y
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