The document discusses strategies for developing biosimilars in a cost-effective manner. It notes that while the biopharmaceutical opportunity is large, biosimilar development faces significant challenges related to regulation, manufacturing complexity, and marketing limitations. Companies therefore pursue various strategies like building internal capabilities, outsourcing non-core functions, partnering, and acquisitions. The document uses Reliance Life Sciences as a case study, outlining its multi-pronged approach to developing an integrated biosimilars pipeline and capabilities through both internal investment and external partnerships and deals.
UL Product Mindset Industry Report Building MaterialsUL
This report is a complement to a global study, Navigating the Product Mindset, that features marketplace trends, statistical data, differing stakeholders, varied geographies, diverse industries and a technical panel of UL experts. This report presents the key findings related to the building materials industry. It is based on 2,430 quantitative interviews with manufacturers and consumers across a range of significant export and import markets — China, Germany, India and the United States.
Navigating the Product Mindset and its additional industry reports seek to better understand market forces; drivers of decisions; findings related to safety, performance, sustainability and innovation; and the motivations behind these views.
This report is a complement to a global study, Navigating the Product Mindset, that features marketplace trends, statistical data, differing stakeholders, varied geographies, diverse industries and a technical panel of UL experts. This report presents the key findings related to the food industry. It is based on 2,430 quantitative interviews with manufacturers and consumers across a range of significant export and import markets — China, Germany, India and the United States.
Navigating the Product Mindset and its additional industry reports seek to better understand market forces; drivers of decisions; findings related to safety, performance, sustainability and innovation; and the motivations behind these views.
The Notion: 5pt BRAND conversation is a brand conversation that is designed to engage consumers with products and services. Effective communication design creates a dialogue and encourages the consumer to start a conversation about their experience in the brand community.
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentech
UL Product Mindset Industry Report Building MaterialsUL
This report is a complement to a global study, Navigating the Product Mindset, that features marketplace trends, statistical data, differing stakeholders, varied geographies, diverse industries and a technical panel of UL experts. This report presents the key findings related to the building materials industry. It is based on 2,430 quantitative interviews with manufacturers and consumers across a range of significant export and import markets — China, Germany, India and the United States.
Navigating the Product Mindset and its additional industry reports seek to better understand market forces; drivers of decisions; findings related to safety, performance, sustainability and innovation; and the motivations behind these views.
This report is a complement to a global study, Navigating the Product Mindset, that features marketplace trends, statistical data, differing stakeholders, varied geographies, diverse industries and a technical panel of UL experts. This report presents the key findings related to the food industry. It is based on 2,430 quantitative interviews with manufacturers and consumers across a range of significant export and import markets — China, Germany, India and the United States.
Navigating the Product Mindset and its additional industry reports seek to better understand market forces; drivers of decisions; findings related to safety, performance, sustainability and innovation; and the motivations behind these views.
The Notion: 5pt BRAND conversation is a brand conversation that is designed to engage consumers with products and services. Effective communication design creates a dialogue and encourages the consumer to start a conversation about their experience in the brand community.
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentech
7th Cold Chain Distribution for PharmaceuticalsAbby Lombardi
Only at the 7th Cold Chain Distribution for Pharmaceuticals, will you have the opportunity to network with the largest group of cold chain professionals, regulators and logistics providers. Key discussions include evaluating transportation strategy from top to bottom, developing KPIs & SOPs when qualifying 3PL providers, considering international shipment and import/export procedures and updates from regulatory agencies on new & proposed guidelines. Plus – don’t miss hearing from industry colleagues on Managing International Cold Clinical Supplies, during the NEW Post-Conference Focus Day.
This presentation contains recommendations and requirements for the design of bioanalytical testing used in comparibility studies for biosimilar drug development using rituximab as an example
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
At least 400 million people worldwide lack access to essential health services and 2 billion cannot afford the medicines they need. Meanwhile, the global cost of healthcare has jumped to 6.5 trillion US dollars. Access is a huge and complex issue, which affects both developing and developed countries.
Today Carol Lynch, our Global Head of Biopharmaceuticals, gave a keynote address to the European Biosimilars Group highlighting how biosimilars can help transform patient outcomes and calling for all stakeholders to work together to build trust and confidence. You can read the presentation here
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
7th Cold Chain Distribution for PharmaceuticalsAbby Lombardi
Only at the 7th Cold Chain Distribution for Pharmaceuticals, will you have the opportunity to network with the largest group of cold chain professionals, regulators and logistics providers. Key discussions include evaluating transportation strategy from top to bottom, developing KPIs & SOPs when qualifying 3PL providers, considering international shipment and import/export procedures and updates from regulatory agencies on new & proposed guidelines. Plus – don’t miss hearing from industry colleagues on Managing International Cold Clinical Supplies, during the NEW Post-Conference Focus Day.
This presentation contains recommendations and requirements for the design of bioanalytical testing used in comparibility studies for biosimilar drug development using rituximab as an example
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
At least 400 million people worldwide lack access to essential health services and 2 billion cannot afford the medicines they need. Meanwhile, the global cost of healthcare has jumped to 6.5 trillion US dollars. Access is a huge and complex issue, which affects both developing and developed countries.
Today Carol Lynch, our Global Head of Biopharmaceuticals, gave a keynote address to the European Biosimilars Group highlighting how biosimilars can help transform patient outcomes and calling for all stakeholders to work together to build trust and confidence. You can read the presentation here
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
Nowadays patients and physicians can have access to three types of drugs: a originators, a generic or a biosimilar.
Those drugs have different regulatory systems that apply in Europe; moreover the biosimilars regulation is evolving and may change. Regulation is an important factor that can give more confidence to patients and healthcare professionals. As a consequence, biosimilaires will grow.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion on biologics, including an explanation of the high level of precision that is required to produce a consistent biological product each time.
● Discussion on the growing interest in biosimilars, followed by what we can learn from Europe’s experience.
● Health Canada’s position on biosimilars, discussion on key issues surrounding biosimilars relevant to the Canadian market.
● The importance of patient safety and patient choice.
View the video: https://youtu.be/h3Ap6HoiSC8
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This is an intro presentation that I put together recently for a client. It just describes some of the tactics that we use to build Spanish links for our clients. It also shows a few ways that you shouldn't build links.
Increasing costs and decreased productivity have hampered growth and investment in the global life sciences and health-care sector. The open-innovation approach embraced by many industries could transform the way biotech and health-care companies innovate—bringing products and services to market quickly and efficiently.
What does this mean for business and consumers in Ontario?
Presenting diverse perspectives, this breakfast panel examines the open-innovation approach and identifies opportunities and challenges for health-care stakeholders as they position themselves in the value chain. Learn how to use this approach and leverage it with success.
Genome Editing Market Analysis By Technology (CRISPR, TALEN, ZFN), By Delivery Method (Ex-vivo, In-vivo), By Application (Animal/Plant Cell Editing), By Service (In-house, Outsourced), By End-use And Segment Forecasts, 2018 - 2025
This webinar, led by Cheryl Silva, introduced a solution for streamlining study start-up activities and tailoring the scope of these activities to coincide with studies of varying complexity. In addition, the challenges driven by tight trial timelines for the data management team was reviewed.
Ws from innovation to commercialisation marcel van der sluisIventus
Presentation of dr. Marcel van der Sluis, Manager BD Drug Development Cluster at the Workshop 'From Innovation to Commercialisation' during the Dutch Life Sciences & Health Conference 2010
In today’s healthcare industry, medicine is becoming more and more personalized with patient focused approach. To drive such a personalized medicine avenue, Biomarker is a good example anda leading contract research organizations (CRO) like CMIC, Inc. have a responsibility to provide bioanalytical data meaningful enough for advanced medicines.
Introductory presentation to an EphMRA Masterclass workshop follow-up webinar given 6 December 2012. The original Masterclass workshop was delivered in Paris June 2012 at the EphMRA '360 Future' conference.
The full recorded webinar will be made available to EphMRA members later in 2013
Similar to C ph i biosimilar presentation - rahul padhye - reliance (20)
C ph i biosimilar presentation - rahul padhye - reliance
1. Reviewing Cost Effective Solutions to Support
Your Biosimilars Strategy
CPhI Worldwide Pre-show Conference
Rahul Padhye
Head, Corporate Development
Paris – Oct 4, 2010
1
2. Contents
1. Biosimilar Development Perspective
2. Strategic Aspects
3. Reliance Life Sciences Context
4. Summary
2
3. Biopharmaceutical Opportunity
Global Pharmaceutical Industry
2009 Revenues
USD 837 billion
Global pharmaceutical revenues
USD 837 billion Biopharma, 90
Global biopharmaceutical
revenues USD 90 billion
Pharmaceutical growth rate 5-8%
Biopharmaceutical growth rate 12-
15 % Small Molecule,
747
Source: IMS
Biopharmaceuticals contribute to about 11% of
pharmaceutical revenues and is growing at 12-15 % p.a.
3
4. Biosimilars Opportunity
US Europe ROW
CAGR
14000 Percent
11,890
12000
10000
+ 57%
47.8
$ Millions
8000
6,411
6000
3,802 53.5
4000
2,434
1,255 1,684
2000
60.4
0
2008 2009 2010 2011 2012 2013
Year
Source: Global Industry Analysts Report (2006), National Coalition on Healthcare, McKinsey
The global biosimilars market potential is substantial.
4
5. Biosimilar Development – Competencies
Molecular Process Quality Clinical Regulatory
Manufacture Marketing
Biology Development Management Research Affairs
Target Bioprocess dev Quality control Pre-clinical Dossiers Upstream Product mgmt.
identification Bioanalytical Quality Toxicity studies preparation Downstream Sales
Gene synthesis dev. assurance Efficacy Regulatory Purification Medical affairs
Gene validation Stability Validation studies interface Fill-finish Pharmaco-
Electrophoresis studies Animal models Intellectual Packaging Vigilance
Stable clone Process scale- Bioassays dev. property Bioprocess Market research
Clone up Clinical control
expression Clinical opns.
Project mgmt.
Biometrics
Medical writing
GXP Compliance
An integrated biopharmaceutical initiative requires several
competencies working seamlessly across the value chain.
5
6. Biosimilar Development - Challenges
Technology
Extensive product characterization
required
Manufacturing complexity
High capital costs for setting up large-
scale manufacturing facility
Higher cost to prove comparability
Regulatory
Need clinical trials which are expensive
Regulatory pathway in US is still unclear
Marketing
Limited discounting ability (discounting
in the range 25-30%) so ability to
compete on price
Brand development and promotional
efforts
Biosimilars are a big opportunity; but is capital intensive with
long gestation period.
6
7. Biosimilar Development -Competitive Advantages
Quality
Precise sequence
Process development
Bioassay specificity and linearity
Cost
High productivity cell lines
Downstream yields
Scaled-up process, particularly
for antibodies
Timelines
In-house development vs.
outsourcing
Clinical development geography
Competitive advantages of quality, cost and timelines are
derived from skills, technology and development strategy.
7
8. Contents
1. Biosimilar Development Perspective
2. Strategic Aspects
3. Reliance Life Sciences Context
4. Summary
8
9. Competency Gaps
Mol. Biology
Regulatory Quality
Management Process Dev
Affairs
High
Manufacturing
Importance
Clinical
Development Marketing
& sales
Low
Intellectual
Property
Low High
Competency Gap
Competency gaps led biosimilar players to adopt different
strategies for product development and commercialization 9
10. Strategies
Strategies
Build
Outsource
Partner
Acquire
Combination of above
Factors
Track record
Expediency
Risk appetite
Profitability aspirations
Biopharmaceutical company can follow several strategies
for product development.
10
11. Outsourcing – Small molecules vs. Biosimilars
Aspect Small Molecules Proteins/MAbs
Product Can outsource product Cell lines are key for biosimilar
development development (chemical product development and
synthesis) to CROs therefore can ideally be
Large no. of CRAM developed in-house.
players provide these Very few CROs provide cell line
services on time and development ability and the fee
materials basis structure involves licensing fees
Manufacturing Can outsource Biosimilars manufacturing is
manufacturing to vertically integrated up to
different manufacturers formulated bulk so one can, at
for drug intermediate, most, outsource fill-finish
bulk drug and formulated operations
drug product
Clinical Easy to outsource Need extensive exercise for
Development clinical trials (BA/BE clinical development , which will
studies) – requires less include pre-clinical studies, Ph 1
time and effort and Ph 3 studies
Outsourcing biosimilars development is difficult compared to
small molecules.
11
12. Outsourcing Options
Areas for Outsourcing
Molecular Process Clinical Regulatory
Manufacture Marketing
Biology Development Research Affairs
Outsourcing Potential
Moderate High Moderate to High Low
CRO/CMO CRO CMO CSO
Cell line development Clinical research Process scale-up
Product Regulatory filings Drug substance
characterization mfg.
Process development Fill/finish
Where to Outsource?
US/EU US/EU + US/EU +
Emerging Markets? Emerging Markets?
Emerging markets can provide cost-time advantage for
biosimilars development.
12
13. Strategies
Strategies
Build
Outsource
Partner
Acquire
Combination of above
Factors
Track record
Expediency
Risk appetite
Profitability aspirations
Biopharmaceutical company can follow several strategies
for its product development.
13
14. Biosimilars Licensing – Objectives
Licensor:
Non-dilutive funding
Recognition/Validation of product
quality
Opportunity to work with Partner on
additional products/areas
Licensee:
Adding to internal product pipeline
Timing – faster to market compared
to internal development
Better product – higher cell line
productivity
Accessing cost competitive product
development and manufacturing
capabilities
Licensing can help each partner achieve its objectives.
14
15. Biosimilar Licensing Deals (1)
Year 2005 2006 2007 2008/2009 2010
Licensor Pliva Stada Biocon Intas Watson
Licensee Mayne Pharma Hospira Abraxis Apotex Itero
Products EPO and GCSF EPO GCSF GCSF, PEG-GCSF FSH
Stada – Germany, Abraxis– NA, UK,
Hospira – NA, EU Germany, Spain,
Pliva – CEE, US
(except Germany) Italy, France (Co- Watson –
and JP; Mayne – Apotex – NA & EU;
Territory (Hospira has the first exclusivity in worldwide
W. Europe, Intas – RoW
right of refusal for all other EU rights
APAC, MENA
countries outside US countries);
and EU) Biocon – RoW
Pliva –
Intas – Watson -
Roles and Manufacturing;
Stada - Complete Manufacturing, Complete
Responsibility Both parties - Not Disclosed
product development Both parties - Co- product
of Parties joint clinical
development development
development
Upfront US$ 21 million US$ 21 Million Not disclosed Not disclosed
US$ 7.5 million
Milestones over 3 years US$ 34 Million Not disclosed Not disclosed
Royalty Not Disclosed Not Disclosed Not disclosed Not disclosed Not disclosed
US$ 21 mn + US$ 7.5 mn +
Total US$ 55 mn + Royalties Not disclosed Not disclosed
Royalties Royalties
Generic pharma companies have done outlicensing deals
for some of the first generation biosimilars (EPO & GCSF).
15
16. Biosimilar Licensing Deals (2)
Partners Biocon & Mylan Teva & Lonza Hospira & Celltrion Hikma & Celltrion
Year 2009 2009 2009 2010
Eight Products Nine Products
Products MAbs MAbs
(most likely MAbs) (most likely MAbs)
Mylan – US,
Canada, EU, JP,
AU,NZ, EU-FTA US, EU, Australia,
Territory Global MENA
countries and co- NZ, Canada
exclusivity with
Biocon for ROW
Celltrion would be
Celltrion would be
responsible for
responsible for
Joint manufacturing &
Roles and manufacturing &
Joint development development supply; Hikma to
Responsibility supply; Co-
by both the parties by both the market the
of Parties marketing of
parties products
products by
exclusively under
partners
own brand name
Deal Structure Profit Sharing Joint Venture Alliance Alliance
Partnerships for product pipelines (mostly MAbs) are the
‘flavor of the season’.
16
17. Biosimilars Licensing - Strategies
Pipeline deal with one partner
Deal management is simple
No flexibility and high risk if
partner is unable to deliver
Licensing deal with multiple partners
Risk is diversified
Alliance management is difficult
Selective partnering – products /
geographies
Risk is diversified
Deal management complex
Timing
Early stage
Late stage
There is no single strategy for licensing. It depends on the
needs of both partners.
17
18. Contents
1. Biosimilar Development Perspective
2. Challenges
3. Strategic Aspects
4. Reliance Life Sciences Context
5. Summary
18
19. Reliance Life Sciences Initiatives
Clinical
Bio- Regenerative Molecular Plant Industrial
Pharmaceuticals Research Biofuels
pharmaceuticals Medicine Medicine Biotechnology Biotechnology
Services
Plasma Pre-clinical Embryonic Molecular Plant Tissue
API Agronomy Biopolymers
Proteins Studies Stem Cells Diagnostics Culture
BA/BE Farm Hematopoietic Plant Metabolic
Biosimilars Formulations Genetics Biochemicals
Studies Advocacy Stem Cells Engineering
Monoclonal Phase 1 Plant Metabolic Ocular Predictive Plant
Antibodies Studies Engineering Stem Cells Diagnostics Products
Phase 2/3/4 Plant Tissue Skin and
Studies Culture Tissue Engg.
Novel Data Mgmt. Cord Blood
Enzymology Repository
Therapeutics & Biostatistics
Trans-
QTc Studies
Esterification
Fusion
Proteins
siRNA
Molecules
Reliance Life Sciences is building one of the most diverse
and integrated life sciences initiatives in the world.
19
20. Biosimilars Product Pipeline
Products in Indian market
Erythropoietin (ReliPoietin™)
GCSF (ReliGrast™)
Interferon (ReliFeron™)
Reteplase TPA (MIRel™)
FSH (FostiRel ™)
Products under development
Cytokines
Interferons
Hormones
Monoclonal antibodies
Blood Factors
Reliance Life Sciences is developing and bringing to market a
range of biosimilars.
20
21. Biosimilars Strategy
Build
Entire value chain
Institutionalized competency
development
Outsource/Access
Product characterization
High-expression cell lines
Cell line development
Clinical development in EU
Partner
Clinical development
(inbound)
Contract manufacturing
(inbound and outbound)
RNA Delivery technologies
Acquire
GeneMedix
Reliance Life Sciences has adopted a multi-pronged strategy
in developing an integrated biopharmaceutical play.
21
22. Contents
1. Biosimilar Development Perspective
2. Challenges
3. Strategic Aspects
4. Reliance Life Sciences Context
5. Summary
22
23. Summary
The biopharmaceutical
opportunity is compelling
Challenges are formidable
Strategic considerations and
responses are critical to
developing biosimilars in a
cost-effective manner
Emerging markets can
provide time-cost advantage
for developing biosimilars
Reliance Life Sciences is a
notable example in context
Developing biosimilars in cost-effective manner in emerging
markets is challenging, but is doable.
23