applied strategic founder, Dr Richard Littlewood defined success factors for the next 10-year commercial phase of biosimilars at the 8th Biosimilars Congregation, held in London.
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.
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
Global Biopharmaceutical Contract Manufacturing Market - Qualitative and Quan...Aiswariya Chidambaram
This presentation which highlights the key market and technology trends in the global biopharmaceutical contract manufacturing market was delivered as a lecture at the In-Focus Seminar session at CPhI Worldwide 2013 held at Frankfurt, Germany.
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.
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
Global Biopharmaceutical Contract Manufacturing Market - Qualitative and Quan...Aiswariya Chidambaram
This presentation which highlights the key market and technology trends in the global biopharmaceutical contract manufacturing market was delivered as a lecture at the In-Focus Seminar session at CPhI Worldwide 2013 held at Frankfurt, Germany.
Merck & co., inc. barclays final 3-10-2015Marcel Brussee
What does Merck's $10B buyback plan say about pharma M&A?
Adding $10 billion to its stock buyback program might mean Merck & Co. ($MRK) wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Source: http://www.fiercepharma.com/story/what-does-mercks-10b-buyback-plan-say-about-pharma-ma/2015-03-26?utm_campaign=SocialMedia
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
COVID-19 Impacts on the Global mRNA Vaccines and Therapeutics Market NarayanSharma67
The “Global mRNA Vaccines and Therapeutics Market” is likely to grow at a CAGR of around 13% during the forecast period, i.e., 2021-26, says MarkNtel Advisors. The market growth essentially attributes to the rising prevalence of infectious and chronic diseases, including HIV, diabetes, cancer, and cardiovascular diseases.
In recent years, the pharmaceutical industry has witnessed increased political interest and attention due to the increased recognition of the economic importance and financial impact of healthcare as a component of national budgets. Biologic drugs (biologics) have attracted the attention of politicians since biologics have moved out of the niche pharmaceutical arena to contribute 17% of global pharmaceutical sales, representing revenues of more than $120bn in 2009. The market for biologics is growing at twice the rate of pharmaceutical drugs, placing significant cost pressures on government, employers, insurers, and patients. Government and insurers are using several strategies to contain costs but must ensure that the financial burden placed on patients does not restrict access to the health care system. Establishing a regulatory pathway for ‘follow-on’ biologics (biosimilars) was therefore felt to be necessary by many stake holders to encourage competition and reduce prices. Many pharmacutical companies both large and small - are expecting their bottom line growth to be driven by biosimilars and are channeling their R&D budgets to compete in what – according to many - is going to be one of the hottest areas in a radically changing global pharmaceutical market.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Merck: Global Health and Access to MedicinesTony Sebastian
This is a HBR case study analysis of Merck, the pharmaceutical company. Detailed analysis of the issues are given in the case like CAGR framework, PESTAL, SWOT etc
SBM-Investor-Presentation-April-2022
Sirona Biochem was founded in 2009 by its current Chairman and CEO, Dr. Howard Verrico. The Company’s first transaction was to acquire an exclusive global license to TFChem’s proprietary diabetes drug, the SGLT2 Inhibitor.
Reducing technical and regulatory uncertinty in biosimilar developmentAjaz Hussain
Reducing risk of Biosimilar product development requires early attention to evidence development and effective communication to multiple stakeholders. Skill set for effective leadership and management, in the US market context, includes ability to: (1) Overcome the ‘blind spots’, (2) Analysis of knowledge, and (3) Evidence logic & communication. This presentation makes these points while comparing the EU and the USA regulatory context and the challenges of integration across multiple scientific and clinical disciplines.
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
http://www.indxx.com/indices.php?id=211 - Thus far in the 21st century, the rise of biologic drugs has been a major theme in the global pharmaceutical industry
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
applied INSIGHTS: 10 year perspective on biosimilars, prediction for success ...Richard Littlewood
Biosimilars, approved highly similar versions of biologic medicines, are >10 years old now, in Europe
applied strategic has worked on strategy for biosimilars since 2007. In China, there is major potential for biosimilars industry success
Merck & co., inc. barclays final 3-10-2015Marcel Brussee
What does Merck's $10B buyback plan say about pharma M&A?
Adding $10 billion to its stock buyback program might mean Merck & Co. ($MRK) wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Source: http://www.fiercepharma.com/story/what-does-mercks-10b-buyback-plan-say-about-pharma-ma/2015-03-26?utm_campaign=SocialMedia
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
COVID-19 Impacts on the Global mRNA Vaccines and Therapeutics Market NarayanSharma67
The “Global mRNA Vaccines and Therapeutics Market” is likely to grow at a CAGR of around 13% during the forecast period, i.e., 2021-26, says MarkNtel Advisors. The market growth essentially attributes to the rising prevalence of infectious and chronic diseases, including HIV, diabetes, cancer, and cardiovascular diseases.
In recent years, the pharmaceutical industry has witnessed increased political interest and attention due to the increased recognition of the economic importance and financial impact of healthcare as a component of national budgets. Biologic drugs (biologics) have attracted the attention of politicians since biologics have moved out of the niche pharmaceutical arena to contribute 17% of global pharmaceutical sales, representing revenues of more than $120bn in 2009. The market for biologics is growing at twice the rate of pharmaceutical drugs, placing significant cost pressures on government, employers, insurers, and patients. Government and insurers are using several strategies to contain costs but must ensure that the financial burden placed on patients does not restrict access to the health care system. Establishing a regulatory pathway for ‘follow-on’ biologics (biosimilars) was therefore felt to be necessary by many stake holders to encourage competition and reduce prices. Many pharmacutical companies both large and small - are expecting their bottom line growth to be driven by biosimilars and are channeling their R&D budgets to compete in what – according to many - is going to be one of the hottest areas in a radically changing global pharmaceutical market.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Merck: Global Health and Access to MedicinesTony Sebastian
This is a HBR case study analysis of Merck, the pharmaceutical company. Detailed analysis of the issues are given in the case like CAGR framework, PESTAL, SWOT etc
SBM-Investor-Presentation-April-2022
Sirona Biochem was founded in 2009 by its current Chairman and CEO, Dr. Howard Verrico. The Company’s first transaction was to acquire an exclusive global license to TFChem’s proprietary diabetes drug, the SGLT2 Inhibitor.
Reducing technical and regulatory uncertinty in biosimilar developmentAjaz Hussain
Reducing risk of Biosimilar product development requires early attention to evidence development and effective communication to multiple stakeholders. Skill set for effective leadership and management, in the US market context, includes ability to: (1) Overcome the ‘blind spots’, (2) Analysis of knowledge, and (3) Evidence logic & communication. This presentation makes these points while comparing the EU and the USA regulatory context and the challenges of integration across multiple scientific and clinical disciplines.
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
http://www.indxx.com/indices.php?id=211 - Thus far in the 21st century, the rise of biologic drugs has been a major theme in the global pharmaceutical industry
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
applied INSIGHTS: 10 year perspective on biosimilars, prediction for success ...Richard Littlewood
Biosimilars, approved highly similar versions of biologic medicines, are >10 years old now, in Europe
applied strategic has worked on strategy for biosimilars since 2007. In China, there is major potential for biosimilars industry success
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
8th Biosimilars Congregation 2016 conference which is taking place at 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK.
For more details and registration simply email your interest and queries to Email – Deepak@virtueinsight.co.in
Best Regards,
Deepak Raj
Delegate and Sponsorship Sales
Virtue Insight
Gsm - + 91 9171350244
Tel - + 91 44 65515693
Skype - edeepakraj143
8th Biosimilars Congregation 2016 conference which is taking place at 08th & 09th March 2016, The Kensington Close Hotel, Wrights Lane, London, UK.
For more details and registration simply email your interest and queries to Email – Deepak@virtueinsight.co.in
Best Regards,
Deepak Raj
Delegate and Sponsorship Sales
Virtue Insight
Gsm - + 91 9171350244
Tel - + 91 44 65515693
Skype - edeepakraj143
Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth.
Download Global biosimilars market regulations & pipeline insightKuicK Research
“Global Biosimilars Market Regulations & Pipeline Insight 2014” Report Highlights:
Market Overview
Detailed Regulatory Pathways For 12 Countries/Regions
Global Biosimilars Pipeline by Phase, Indication, Company & Country
Biosimilars Pipeline: 276 in Development Phase
Majority Biosimilars in Preclinical Phase: 76 Biosimilars
Marketed Biosimilars by Indication, Company & Country: 113 Biosimilars
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Defecation
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applied strategic biosimilars success
1. applied strategic
10 years experience in biosimilars: launch
to the future. What matters most?
Presentation by Dr Richard Littlewood
9 March 2016
8th Biosimilars Congregation
applied strategic 1
2. Analytics
What we all know? Definition of similarity concept for
biologic medicines defined a new market for biosimilars
applied strategic 2
Preclinical
PK/PD
Clinical
Trials
Process
development
Source: McCamish 2011, CMHP/437/04
Biological
Characterization
Physiochemical
Characterization
“A company may choose to
develop a new biological medicinal
product claimed to be “similar” to a
reference medicinal product”
CHMP/437/04
3. What do we expect? Rapid growth to $35B global market
for biosimilars, predicted by observers
applied strategic 3
Biosimilars global sales
[2013-2020, $B]
60%
CAGR
Biosimilars
Biologics
175
285
2013 2020
Source: Merck Serono 2014, Blackstone & Joseph 2013, EGA 2015, Evaluate Group 2014
4. When did it start? Radical regulatory affairs innovation by
EMEA, 2004 and key guidance launched biosimilars
applied strategic Source: applied strategic analysis EMA
Legal progress
Regulatory progress
2001 2002 2003 2004 2005 2006
Directive 2003/63/EC
“Annex I” biosimiars
recognition
Directive
2004/27/EC
published
Directive
2004/27/EC
in law
First
biosimilar
approved
Product
guidelines
hGh, insulin,
EPO, G-CSF
Comparability
guidelines
Quality, non-
clinical,
clinical
guidelines
5. Where did it start? In Europe work started pre-2000;
alternative biologics versions were marketed in LATAM also
applied strategic 5
Europe
1998: Start development of
Binocrit® (epoetin alfa)
Mexico
1999: launch of Bioyetin
(epoetin alfa)
Source: applied strategic analysis
6. What is the impact? Early product launches in Europe
highlight commercial and patient access success
applied strategic 6
• Launch of biosimilar Epoetin
alfa in Europe
• 5 year healthcare cumulative
savings to Germany, €0.6B
• Typically 35% cost reduction
• 255,000 patient-years
exposure
Biosimilar Epoetin Alfa
Launch 2007
Commercial & patient access
success
Source: applied strategic analysis
7. What is the impact? A relatively small set of biosimilar
products are currently marketed
applied strategic 7
Omnitrope
Silapo
EpoHexal
Binocrit
Abseamed
Tevalgrastim
Ratiograstim
Biograstim
Retracrit
Nivestim
Remsima
Ovaleap
Inflectra
Grastofil
Bemfola
Accofil
Abasglar
Benepali
Zarzio
FilgrastimHexal
20162006 2011
Source: GaBI, Biosimilars approved in Europe 2016
European product approvals
8. What is the impact? Few companies own a majority of the
assets: market looks an oligopoly…
applied strategic 8
Omnitrope
Silapo
EpoHexal
Binocrit
Abseamed
Tevagrastim
Ratiograstim
Biograstim
Retracrit
Nivestim
Remsima
Ovaleap
Inflectra
Grastofil
Bemfola
Accofil
Abasglar
Benepali
Zarzio
FilgrastimHexal
20162006 2011
Source: GaBI, Biosimilars approved in Europe 2016
European product approvals
Assets owned by companies with
portfolio of biosimiars
9. What is the future? Patent expiry, freedom to operate for
many biologics defines a $B expansion of opportunity
Monoclonal antibodies approved/ under review in EU/ US
[Patent expiry]
applied strategic 9
Oncology
Non-
oncology
17
32
<2020 >2020
Source: applied strategic analysis
• 49 monoclonal antibody
products have potential for
biosimilar launch
• Launch of biosimilar
versions of these products
represents a step change
in opportunity size
Potential value $20-30B
Expiry of
patent, year
10. What is the future? New biosimilar products – based on
antibodies – imply increasing manufacturing complexity
applied strategic 10
Trade Name (INN) Originator Approval date
Tysabri® (Natalizumab) Biogen Idec 2004
Lucentis® (Ranibizumab) Roche/ Novartis 2006
Cimzia® (Certolizumab) UCB 2009
Stelara® (Ustekinumab) Johnson & Johnson 2009
Eylea® (Aflibercept) Bayer/ Regeneron 2011
Zaltrap® (Aflibercept) Sanofi/ Regeneron 2012
Prolia®/Xgeva® (Denosumab) Amgen 2011
Benlysta® (Belimumab) GlaxoSmithKline 2011
Soliris® (Eculizumab) Alexion 2007, 2011
Source: applied strategic analysis
• Future products with potential to be biosimilars are based on antibodies
• Greater manufacturing complexity, defining a special capability need
11. What is the future? Success with biosimilars is driving
increasing simplicity in evidence needed for approval
applied strategic 11
“a confirmatory clinical trial may
not be necessary”
EMA 2014
“waiving clinical trials may be
accomplishable for biosimilar
rhG-CSF”
EMA 2015
“pre-licensing safety study,
immunogenicity assessment
waived?
EMA 2015
“PK PD results may make a
comparative efficacy study
unnecessary”
FDA 2015
Source: applied strategic analysis
12. What is the future? A broad range of competitors now are
present: partners are a major part of the business
applied strategic 12
Merck Sorono, Merck
Pfizer, Daiichi-Sankyo
Boehringer Ingelheim,
biogen idec
Baxter, Lilly, Amgen
Sandoz, Teva
Hospira, Mylan
STADA, Dr. Reddy’s,
actavis. Cipla, Gideon
Richter
Fujifilm
Samsung
GE Healthcare
Celltrion
Innovative
companies
Generics
manufacturers Others
Biocon
Lonza
Formycon
Patheon
Intas
IBA Bioton
Zydus
Broughton
Zydus
Wockhardt
CMC
Rentschler
Key partners: supporting development, contract development, manufacturers
Competitors: Commercializing biosimilar products
Source: applied strategic analysis
13. What drives success? First commercial phase. Success
factors: protein characterization, regulatory affairs
applied strategic 13
Development Clinical Regulatory Launch Commercial
Cell line to product
development; protein
characterization;
comparability
Agency relationships,
strategic leadership;
pathway interpretation
Tender management,
pricing strategy.
Customer awareness
Customer awareness,
defending against
restrictions;
Policy management
Success Factors for Biosimilar Competition: First Commercial Phase
(2006-2016)
14. What drives success? Next 10 years Success factors:
commercial power, speed to market
applied strategic 14
Development Clinical Regulatory Launch Commercial
Complex protein
manufacture
R&D partnerships
Capability to delivery
clinical studies rapidly
Marketing & Sales
power
Race to market
Success Factors for Biosimilar Competition: Second Commercial Phase
(2017-2027)
15. Speaker profile
Dr. Richard Littlewood
• Richard is the founder of the strategy firm
applied strategic
• is a physician with clinical practice experience
and a management consultant who has worked
for 15 years addressing strategic and operational
issues in health, pharma
• He is a UK GMC registered physician, has an
MA from Trinity College, Cambridge and is a
graduate of the Sloan Masters management
program at London Business School.
• Richard pioneered on biosimilars strategy and
has extensive experience in many developed
and emerging markets.
15
[appliedstrategic founder]
Dr. Richard Littlewood
• Adviser to global pharmaceutical companies
involved in biosimilar development in Europe,
USA and emerging markets since 2006
[Conflicts]