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Biosimilar Market Trends –
the ones to watch
4 April 2019
Randall Crisp
Life Sciences Regional Manager, Sub Saharan Africa
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More than a century and a half of trusted insights
BIOSIS founded by Society of Bacteriologists and Botanical SocietySCIENTIFIC AND ACADEMIC RESEARCH
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Zoological Society of London and
British MuseumSCIENTIFIC AND
ACADEMIC RESEARCH
Dr. Eugene Garfield invents citation indexing
and searchingSCIENTIFIC AND
ACADEMIC RESEARCH
Monty Hyams begins selling patent bulletins
from his home, DerwentIP AND STANDARDS
ISI foundedSCIENTIFIC AND ACADEMIC RESEARCH
1864
1926
1955
1957
1963 1980s
1997
2011
2012
2016
2017
Thomson acquired trademark research companies Thomson & Thomson and COMPUMARK
Web of Science launchedSCIENTIFIC AND
ACADEMIC RESEARCH
Cortellis launchedLIFE SCIENCES
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MARKMONITOR
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ACADEMIC RESEARCH
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Scientific and academic research
Patent research intelligenceIndustry codes and standards
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Trademark researchand protection
Domain and brand protection
A portfolio of trusted brands
Web of
Science
Derwent
TechstreetCortellis
CompuMark MarkMonitor
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AcademicInstitutions
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Governments BioPharma Innovators
Trusted by top 50 pharma companies
78%of publicly-traded biotechs
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- GOOGLE CEO SUNDAR PICHAI.
10
The market by numbers
234
1152
7464
Launched drugs
Deals
Clinical trial starts
11
SSA As A Major Pharmaceutical Market
• The pharmaceuticals market in Africa is expected to reach a business opportunity of $45 billion in 2020, propelled by a convergence of changing economic profiles, rapid urbanization, increased healthcare spending and investment, and increasing incidence of chronic lifestyle diseases.
• With the increasing adoption of Western lifestyle in Africa, there has been a paradigm shift in the burden of illness towards non-communicable diseases (NCDs), driving the demand for chronic prescription drugs.
• Between 2005 and 2015, six of the world’s 10 fastest-growing countries were in SSA – Angola, Nigeria, Ethiopia, Chad, Mozambique and Rwanda. In eight of the past 10 years, SSA has grown faster than Asia. In 2020, the International Monetary Fund expects Africa to grow at a rate of 6% - about the same as Asia. Continuing such trends, it is estimated that by 2035, Africa’s workforce, which is larger than any other continent, will be making significant strides in the fields of agriculture, healthcare, manufacturing, hospitality and technology.
Rank CountryMarket ($MM)
Rank CountryMarket ($MM)
1 USA 339,694
2 Japan 94,025
3 China 86,774
4 Germany 45,828
5 France 37,156
6 Brazil 30,670
7 Italy 27,930
8 UK 24,513
9 Canada 21,353
10 Spain 20,741
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o Innovative biologics treat challenging diseases, but high cost is creating economic challenges in all markets.
o What are biosimilars and why are they important?
o How have countries gained traction in the biosimilars business?
The role of a strong regulatory and public policy framework.
The impact of favorable commercial policies.
o What does the changing manufacturing landscape tell us?
Overview
13
Funding Challenges
14
Who are filing patents in South Africa?
193
196
230
231
245
309
327
371
401
473
492
499
509
581
637
0 100 200 300 400 500 600 700
MICROSOFT CORP
ASTRAZENECA AB
COLGATE PALMOLIVE CO
PROCTER & GAMBLE CO
ERICSSON CO LTD
HOFFMANN LA ROCHE AG F
SANOFI
DOW AGROSCIENCES LLC
NOVARTIS AG
HINDUSTAN UNILEVER LTD
CONOPCO INC
BAYER PHARMA AG
NESTEC SA
UNILEVER LTD
BASF SE
TOP CORPORATIONS – LAST FIVE YEARS
20
20
20
22
24
25
37
43
44
53
57
74
0 10 20 30 40 50 60 70 80
UNIV NORTH WEST
UNIV TEXAS SYSTEM
UNIV MANDELA METROPOLITAN NELSON
UNIV PENNSYLVANIA
KOREA INST SCI & TECHNOLOGY
INSERM
UNIV CHINA MINING & TECHNOLOGY
UNIV CALIFORNIA
UNIV CAPE TOWN
UNIV WITWATERSRAND
UNIV STELLENBOSCH
INST FRANCAIS DU PETROLE
TOP ACADEMIC INSTITUTIONS – LAST FIVE YEARS
The chances of success
Nu
mb
er
of
Tria
ls
Start Year
Clinical Trial Starts BRIC Countries 2007-2016
Nu
mb
er
of
Tria
ls
Start Year
Clinical Trial Starts SSA and MENA 2007-2016
18
Top Sponsors for Clinical Trial Starts SSA : 2007-2016
Number of Trials
Spo
nso
r
19
Seven new drugs will launch in 2019 and achieve blockbuster sales of more than $1 billion by 2023
20
How they got here: Regulatory status for Cortellis Drugs to Watch 2019
21
Roche’s Africa Strategy
o Initiated in 2015
o Increase access to Roche innovative medicines.
o Create long-term sustainable business opportunity
o A focus on 20 countries and two therapy areas based on unmet medical need.
Viral hepatitis
Cancer (breast, ovarian, cervical)
Roche implements new strategy to being innovative medicines to patients on the continent
The challenge• Average growth in GDP of 5% per year since 2005• 150 million with HepB in 2012• 400,000 women die from breast cancer every year • 54,000 women die from cervical cancer every year.
Source: www.roche.com/media/store/roche_stories/roche-stories-2015-06-24.htm
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o Economic considerations 200% increase in Africa’s foreign trade since 2000
10-fold increase in foreign investment in SSA since 2005
Largest economies: Nigeria, South Africa
Only 30 % to 35% of medicines produced locally (Nigeria)
Healthcare companies not among top 70 (SSA)
o Priorities access to market (harmonization across countries)
safety (counterfeit drug trade)
cost (over-regulation)
Healthcare challenges – Regulatory environment
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Beyond just little pills
• Many generics companies are adding more complex formulations and dose delivery technologies to their portfolios.
• Controlled release or long acting formulations (e.g., emulsions or microspheres) .
• A shift from small molecule chemical APIs to more complex HPAPI and biologic APIs requiring more specialized, expensive and sometimes dedicated plants.
• Sterile injectables or otic and ophthalmic administrations.
• Drug-device combinations (e.g., auto-injectors, respiratory devices and transdermal patches and film).
• Proteins, peptides and other structures that straddle the small molecule chemical and large molecule biological space from a production and regulatory perspective.
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World API manufacturing landscape
1%
6%
9%
15%
57%
12%
Big Pharma
Established
Less Established
Potential Future
Local
Unrated
Source: Newport Premium
• Only 16% of manufacturers, some 521 companies (those rated “Established” and “Less Established”).
• 472 or 16% are rated “Potential Future” denoting limited regulated market experience over a short period.
• 57% of the industry (1874 corporations) is made up of “Local” manufacturers who are only capable of supplying their domestic market and unregulated countries.
• “Established” producers who have many years of experience supplying large numbers of APIs to highly regulated markets such as Europe, North America and Japan make up only 6% of the industry.
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Where are experienced manufacturers located?
Source: Newport Premium
• Established and Less Established API manufacturing is heavily concentrated in US, China, India and Italy and there has been little evidence over the years, of production moving to other emerging countries as some observers had predicted in the past.
• South Korea, Russia, Brazil and Argentina have any significant API industry, much of which has developed in recent times as governments have provided incentives to reduce dependence on foreign API imports and to encourage local innovation and capacity-building in API development and production.
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Deal making landscape 2017
• In all, 13 of the 23 blockbuster licensing deals in 2017 – those in excess of $1B – involved discovery stage assets, including three of the top four. In all, 10 of the blockbusters were in oncology, including five at the discovery phase.
• Average 2017 deal value = $299M
• $8.5B Oncology mega deal between Merck and Astrazeneca.
• Over the last 5 years:
• 164 Oncology deals
• 2 204 licensing, joint ventures and research collaborations
• $244bn aggregate dollar value
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2019 Blockbuster deal
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Regulation and policy impact innovation and market uptakeD
evel
op
men
t Defined biosimilar approval pathway
Europe led the way in 2005
Manufacturing Guidelines define analytical standards for proving similarity
Pre-clinical and clinical evaluation
Defined studies to demonstrate, safety, efficacy and comparability
Co
mm
erci
aliz
atio
n
Substitution and interchangeability
Impacts how biosimilars are prescribed and delivered to patients at the pharmacy
Product naming Proprietary vs. non-proprietary naming conventions impact traceability as well as stakeholder perceptions
IP and market exclusivity Market exclusivity determines when a biosimilar can be launched
Extrapolation of indications Expedites broader therapeutic application of approved biosimilars
Pricing policies and practices Determine if biosimilar will be priced competitive to brand
30
Innovation drives new generic product launch opportunities
Source: 2016 CMR Factbook
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Biopharma Financing-deal money by therapeutic area 2017-2018
32
The rising cost of originator biologics is an economic problem – even for the US
5%
18%
2015 spending on Rx drugs
2015 spending on oncology drugs
Average cost of cancer therapy
$11,325
$1,869
2000 2014
32%
62%
Biologics contribution to US
government health spending
$9 B in 2005
$18.5 B in 2015
33
Notable biologics treat challenging diseases
Drug Indication Developer WW revenue- 2017
Herceptin Cancer Roche $7B
Avastin Cancer Roche $7B
Rituxan Cancer Roche $8B
Lantus Diabetes Sanofi $5B
Humira Autoimmune/Inflamm Abbvie $18B
Remicade Autoimmune/Inflamm JnJ $8B
Enbrel Autoimmune/Inflamm Amgen $8B
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The burden of selected diseases that are treatable with advanced biologics
Prevalence
USSouth Africa Kenya Nigeria Ethiopia
Breast cancer
3.6M 38,000 13,000 52,000 -
Diabetes 29M/8.8% 3.2M/9% 750K /3% 3.9M/4% 1.8M/3.8%
RA 3.8%* 2.5%** - - -
*Age 21+ **Urban settings
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Biologics launched in Africa focus on diabetes
Brand Marketer Indications
bevacizumab Avastin Roche Cancer
canakinumab Ilaris Novartis Autoimmune disease and cancer
liraglutide Victoza Novo Nordisk Neurodegenerative disease
insulin
degludecTresiba Novo Nordisk Diabètes
belatacept Nulojix BMS Transplant
insulin lispro Humalog Lilly Diabetes mellitus
becaplermin Regranex JnJ Diabetic foot ulcer
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Are the most innovative biologics reaching SSA patients in need?
20Notable biologicsUS Launch
South Africa Lag
Humira(Abbvie)
mAb 03 06 +3 yrs
Rituxan(Roche)
mAb 97 99 +2 yrs
Neulasta(Amgen)
protein 02 10 +8 yrs
Enbrel (Amgen) mAb 98 04 +6 yrs
Remicade (JnJ) mAb 98 00 +2 yrs
Avastin (Roche) mAb 04 06 +2 yrs
Herceptin(Roche)
mAb 98 01 +3 yrs
Epogen(Amgen)
Protein 89 90 +1 yr
Lantus (Sanofi) Protein 01 03 +2 yrs
How are other countries getting traction with biosimilars?
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Germany : 1/5 of global biosimilars market and 34% of European market
Product Manufacturer Launched
filgrastim Hospira 2010
follitropin alfa CVC 2018
somatropin Sandoz 2006
rituximab Celtrion 2017
rituximab Sandoz 2017
etanercept Sandoz 2017
lipegfilgrastim BioGeneriX 2013
epoetin alfa Sandoz 2007
erythropoietin Hospira 2008
filgrastim Sandoz 2010
filgrastim CTA 2009
erythropoietinStada
2008
12 biosimilars launched in Germany since 2006
• Support from Germany's Federal Healthcare Committee
• Education; Physician and patient acceptance
• No automatic substitution at pharmacy
• Quotas and incentives
• Tenders and open house contracts with Statutory Health Insurances
39India’s robust biosimilars presence driven by local players and partnerships
Indian Manufacturers or Suppliers
Selected brands Brand status in India
Torr-ent
Reliance Lupin Zydus-Cadila
Intas Biocad Hetero Epirus/Ranbaxy
Biocon Pan Pharm
Cipla
Adalimumab (Humira)
Rituximab (Rituxan)
Bevacizumab (Avastin)
Filgrastim (Neupogen)
Trastuzumab(Herceptin)
Infliximab (Remicade)
Teriparatide (Forteo)
Pegfilgrastim (Neulasta)
Lantus (insulin glargine)
L
L
R
L
L
L
L
L
L
L
L
L
L
L
L
L 3
3
3
*Selected drugs, Phase III and above.
L
L
LL
Source: Cortellis
L RL
L Launched Not launched
L
L
R Registered 3 Phase 3
40Major producers are active in South America but only locals have launched
South AmericaPop 422 million
Manufacturer or Supplier
Brand Status
Coherus/ Daiichi
Amega
LaboratorioFranco
Pfizer Celltrion Amgen MylanBiocon
Mab-xience
BI Sandoz CFR Biosidus
Adalim(2)
Ritux
Bevaciz
Trastuz
Inflixi(1)
Etaner
ROC
L
L
L ABBV
3
L
R
ROC
ROC
JnJL
3
3
L
3 33L
3
3L 3 L R
3
LL PFE
Source: Cortellis
41
Russia relies on local Biocad for it’s biosimilars pipeline
RUSSIA (pop. 144million)
Manufacturer or Supplier
Brand Statts BI Biocad R-Pharm
Celltrion USV Bioepis Hexal Allergan Pfizer
Adalimumab
Rituximab
Bevacizumab
Trastuzumab
Infliximab
Etanercept
Teriparatide
3
L
L ROC
L ABBV
L
L
MerckL
3
ROC
ROC
3
3
3
3
L
L
3
3
3
3
R
Source: Cortellis
42
South Africa (pop. 57 million
Manufacturer or Supplier
Brandstatus
BI PFE MabXcience
Elea Teva/Cipla
Libbs SNDZ Coherus Archigen Mylan BioCad
Adalimumab(Humira)
Rituximab(Rituxan)
Bevacizumab(Avastin)
Filgrastim(Neupogen)
Trastuzumab(Herceptin)
Infliximab(Remicade)
Insulinglargine(Lantus)
L
L DDDD
L
D
DD DD D
L D D
DD
DL
Sub-Saharan Africa – slow to move biosimilars to approval and launch with no local players
L
L
L
43
Greater treatment options and increased access to innovative biologics
Biosimilars could reach 1.2 million patients by 2025*.
Why are biosimilars important?
Humira (adalimumab) Herceptin (trastuzumab) Lantus (insulin glargine)
Autoimmune and
inflammatory diseasesBreast cancer Type 2 diabetes
*biosimilarscouncil.org
Cost savings
USA (2017 to 2026) $54B (24 to 150B) RAND Corporation
Germany (2016 to 2020) 15B QuintilesIMS.
South Africa (per year) 6.4M napm.co.za
44
Key takeaways
• Demand for generics and biosimilars is continuing to increase.
• Market dynamics are changing.
• Innovation is key to speed and lower costs.
• Need for access to manufacturing capabilities to play in specialty products.
• Without access to high quality API, you cannot have high quality generics.
❑ Biosimilars offer a way to bring innovative biologics to patients in need who cannot normally afford them.
❑ The need for biosimilars may be the greatest for patients in Low and Medium Income Countries where brand biologics are unaffordable.
❑ A strong regulatory framework that balances the assurance of quality and safety with policies that facilitate the commercialization of biosimilars are key.
❑ Sub-Saharan African countries have taken the right steps toward establishing a regulatory and policy framework.
❑ The first regulatory frameworks in SSA have only been finalized in the last 6 years
❑ Note that it has taken almost 10 years to get 12 biosimilars approved in the US
45
