BIOSIMILARS : Regulation and Market Trends

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.

Transcript

1. 03/04/2016 1 BIOSIMILARS : Regulation and Market Trends Joseph Pategou International Strategy and Influence
2. 03/04/2016 Regulatory issues on the development of Biosimilars – Joseph Pategou 2 SUMMARY Executive Summary Introduction I. Methodology II. Global economic situation III. Regulation and market trends of Biosimilars IV. Strategic positioning for Originators Conclusion Appendix
3. 03/04/2016 3 EXECUTIVE SUMMARY: 7 Key Points Regulatory issues on the development of Biosimilars – Joseph Pategou  Reduction of health spending in OECD countries  Clear difference between Biosimilars and Generics  EU: the most advanced market for Biosimilars  Substitution and interchangeability are great issues for all actors  Germany: the most favorable regulation for Biosimilars  Regulation issues on Biosimilars evolve quickly  10 levers of Originators to face Biosimilars
4. 03/04/2016 4 INTRODUCTION Regulatory issues on the development of Biosimilars – Joseph Pategou
5. 03/04/2016 5 Introduction to Biosimilars  A Biosimilar is a biological medicine that is similar to, but not identical to, another biological medicine that has already been approved  Due to its complex molecular structure and unique manufacturing process, a Biosimilar is not a copy of its originator biologics  Concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004  EU is the first region in the world to have set up a legal framework and a regulatory pathway for Biosimilars  EU regulatory framework inspired many countries(Australia, Canada, Japan, USA) Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC
6. Which regulatory framework for Biosimilars in Europe? 03/04/2016 6 Research Question Regulatory issues on the development of Biosimilars – Joseph Pategou What strategic positioning for the Originator manufacturers?
7. 03/04/2016 7 METHODOLOGY Regulatory issues on the development of Biosimilars – Joseph Pategou
8. 03/04/2016 8 METHODOLOGY: 3 Steps  Scope of the study: France, United Kingdom, Germany and Italy 1. Identify difference between Generics and Biosimilars  Secondary data 2. Identify the position of main actors  22 interviews  4 types of organizations  10 questions  6 topics 3. Benchmarking  13 companies  Example: Amgen  From 2000 to 2015 Regulatory issues on the development of Biosimilars – Joseph Pategou Sample of the interviews
9. 03/04/2016 9 Source: Interview Bx: Biosimilars Unions Regulatory issues on the development of Biosimilars – Joseph Pategou Sample of the Interviews Types of Organizations Numbers Unions 6 (Bx: 4) Learned Societies 7 Patient Associations 3 Authorities 4 Others 2 LIEN HYPERTEXTE
10. 03/04/2016 10 GLOBAL ECONOMIC SITUATION Regulatory issues on the development of Biosimilars – Joseph Pategou
11. 03/04/2016 11 ECONOMIC SITUATION: Reduction of health spending  The total spending of health is declining since 2009 in OECD countries  The most affected by the economic crisis are the main concerned for the Panorama health 2013 of the OECD  In this context, countries must make their health systems more:  Productive  Efficient  Affordable  Countries reduce spending:  Lower prices of medical goods  Budgetary restrictions  Wage cuts in the hospital sector  Example of France and Germany 12% 11% Regulatory issues on the development of Biosimilars – Joseph Pategou Source: OECD
12. 03/04/2016 12 REGULATION Regulatory issues on the development of Biosimilars – Joseph Pategou Naming Interchangeability Substitution SmPC Extrapolation Marketing Authorization WHO National Authorities EMA DECISION MAKER 6 KEY TOPICS
13.  Suggestion of the World Health Organization:  4-letter code at the end of every drug name  Draft form (not implemented)  Link to manufacturer and manufacturing site of the active substance  All biologicals with INNs  Example: “epoetin lambda bcde” Position of the interviewees on Naming  Difference of position:  Right approach: BQ allows identification and traceability  Wrong approach: BQ gives the perception of important differences between Biosimilar and Originator 03/04/2016 13 Naming DECISION MAKER WHO BQ: Biological Qualifier Regulatory issues on the development of Biosimilars – Joseph Pategou Source: WHO 100% 100% 50% 50% 100% 0% 20% 40% 60% 80% 100% Authorities Patient Associations Learned Societies Unions Right approach Wrong approach
14. 03/04/2016 14 SmPC  European Medicines Agency  The SmPC of the Biosimilar product need to be consistent with the SmPC of the reference product  The SmPC must include the notion of Biosimilar and a reference to the EMA website for further information Position of the interviewees on SmPC  Difference of position:  Identical SmPC: No clinical differences between the Biosimilar and Originator  Different SmPC : Will be of help and allow comparison DECISION MAKER EMA Regulatory issues on the development of Biosimilars – Joseph Pategou Source: EMA 100% 33% 20% 80% 67% 80% 20% 0% 20% 40% 60% 80% 100% Authorities Patient Associations Learned Societies Unions Identical SmPC Different SmPC
15.  Substitution is the pratice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber 03/04/2016 15 Substitution DECISION MAKER National authorities Country Substitution United Kingdom Not authorized France Decree Pending Italy Not authorized Germany Possible between Biosimilars 11% 89% 0% 20% 40% 60% 80% 100% 4MM Substitution No substitution Position of the interviewees on Substitution  Difference of position:  No substitution: The decision to treat a patient with a Biosimilar should be taken by a qualified healthcare professional and the patient 4 MM: Masse Markets : Italy, UK, Germany and France Position of each country on Substitution Regulatory issues on the development of Biosimilars – Joseph Pategou Source: See appendix
16. 03/04/2016 16 Interchangeability DECISION MAKER National authorities  Interchangeability: an important topic  Interchangeability is the medical practice of changing one medicine for another that is expected to achieve the same clinical setting and in any patient on the initiative, or with the agreement of the prescriber  Germany has accepted the principle of interchangeability, for the Paul-Ehrlich-Institute “Biosimilar medicines can be prescribed to patients, who previously have not received any treatment with biologics, as well as those patients who have previously received the original molecule”  In the United Kingdom, interchangeability is permitted for Biosimilars and rests with the responsible clinician in consultation with the patient  Absence of interchangeability in Italy and France  This situation will evolve due to the international context (scientific data available and other countries) Regulatory issues on the development of Biosimilars – Joseph Pategou Source: FDA
17.  European Medicines Agency  Extrapolation is the scientific concept of granting a clinical indication to a medicine without requiring new clinical efficacy and safety data to support an indication  If Biosimilarity has been demonstrated in one indication, extrapolation to other indications of the reference product could be acceptable with appropriate scientific justification ( eg: clinical experience)  Difference of position:  Extrapolation: Biosimilars comparability has been demonstrated in one indication  No extrapolation: Biosimilars are not identical to the Originators 03/04/2016 17 Extrapolation DECISION MAKER EMA Position of the interviewees on Extrapolation Regulatory issues on the development of Biosimilars – Joseph Pategou Source: EMA 100% 65% 60% 100% 35% 20% 0% 20% 40% 60% 80% 100% Authorities Patient Associations Learned Societies Unions Extrapolation No extrapolation
18. Comparison of the MA between Originators, Generics, and Biosimilars  Comparative studies in terms of :  Quality  Safety  Efficacy  Aim to demonstrate that these three parameters are similar to the Originator 03/04/2016 18 Marketing Authorization File of the demand of MA Originators Generics Biosimilars Module 1 Administrative Information Yes Yes Yes Module 2 Summary of Module 3, 4 and 5 Yes Yes Yes Module 3 Quality (manufacturing process) Yes Yes Comparative studies Module 4 Safety (non-clinical studies) Yes Not required Comparative studies Module 5 Efficacy (clinical studies ) Yes Bioequivalence Study Comparative studies DECISION MAKER EMA Regulatory issues on the development of Biosimilars – Joseph Pategou Source: EMA
19. 03/04/2016 19 Key Learnings KEY POINTS DIFFERENCE IDENTICAL Naming x SmPC x Substitution x Marketing authorization x Interchangeability x The most favorable countries in terms of regulation Regulatory issues on the development of Biosimilars – Joseph Pategou Germany 6 KEY TOPICS United Kingdom 6 KEY TOPICS France 6 KEY TOPICS Italy 6 KEY TOPICS Comparison between Biosimilars and Generics Favorable Less favorable  Germany has the most favorable regulation for biosimilars  One commun point between Biosimilars and Generics regulation
20. 03/04/2016 20 MARKET TRENDS Regulatory issues on the development of Biosimilars – Joseph Pategou
21. 03/04/2016 21 Global Picture Global market:  2,6 billion$ in 2015  25 billion$ in 2020  Due to a new market  Biosimilars sales by Region First Biosimilar medicine approved by European Commission Regulatory issues on the development of Biosimilars – Joseph Pategou Source: IMS and EGA Focus on EU :  Most advanced market  11% of total biologics sales in 2011  50% of the off-patent biological market in 2020 20 Biosimilars (7 actives substances) in 2015 Biosimilars market in volume and value in 2011
22. 03/04/2016 22 Source: IMS Regulatory issues on the development of Biosimilars – Joseph Pategou Anti-TNF, Insulins and Onco MABs are the key biologics LIEN HYPERTEXTE
23. 03/04/2016 23 Regulatory issues on the development of Biosimilars – Joseph Pategou Source: BioTrends Research Group A: Actual ; F: Forecast $ billion USA EU Japan Biosimilars Sales by Region LIEN HYPERTEXTE
24. 03/04/2016 24 Main Actors Regulatory issues on the development of Biosimilars – Joseph Pategou Source: IMS and EGA  4 Categories of Players  Top 3 Innovator Companies affected by Biosimilars
25. 03/04/2016 25 Regulatory issues on the development of Biosimilars – Joseph Pategou 4 Categories of Players LIEN HYPERTEXTE
26. 03/04/2016 26 Regulatory issues on the development of Biosimilars – Joseph Pategou Source: IMS and EGA Amgen AbbVie Roche Top 3 innovator companies affected by Biosimilars Innovator companies affected by Biosimilars LIEN HYPERTEXTE
27. 03/04/2016 27 Evolution of Biosimilar and Originator manufacturing cost -8% -10% -15% -16% -13% -10% -7% -4% -1% Y 0 Y 2 Y 5 -25% -30% -50% -55% -35% -15% Y 0 Y 2 Y 5 0 Evolution of retail price for Originators Evolution of hospital price for Biosimilars  Before the arrival of a Biosimilar on the market, we observe a price cut of 10% and 15%  Example: APHP bought Inflectra after the company offered a discount of 45 percent Our interviewees vision on the evolution of price Regulatory issues on the development of Biosimilars – Joseph Pategou Source: APHP, Reuters Outside the Scope
28. 03/04/2016 28 Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Bloomberg & IMS Outside the Scope Remicade Biosimilars Countries Companies Name of the drug Discount Market Share in 2015 Norway Orion Pharma Remsima 72% 70% Poland Hospira Orion Pharma Inflectra Remsima 51% - 69% 67%* *Market share of Inflectra and Remsima in Poland What strategies for these companies?  Cost Strategy • Looking for Experience Effect (loi de Wright) • Looking for more Market Share  User Experience Strategy • Identify the Value Creation of the drug • Have more Clinical Data on the drug  Open the doors to Interchangeability and Subtitution LIEN HYPERTEXTE
29. 03/04/2016 29 Leadership Position of Originators The interviewees think that the market share of Originators will depend on 4 factors: 4 Factors Regulation Trust Cost Adaptability Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview
30. 03/04/2016 30 Choosing between biosimilars of the same reference product The interviewees think that 3 factors influence the choice of a biosimilar: 3 Factors Clinical trial data Price Manufacturer site Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview 1 3 2
31. 03/04/2016 31 Biosimilars and Generics: Nature, Regulation and Market trends Comparison between Biosimilars and Generics in terms of Nature, Regulation and Market trend, the position of the interviewees:  Difference of position:  Not comparable: The biosimilars differ in the complexity of the manufacturing process, large complex molecules and the inherent variability in the biological systems used  Comparable: The common point between biosimilars and generics is only the drop in drug prices and loss of patents Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview 20% 40% 100% 100% 80% 60% 0 0,2 0,4 0,6 0,8 1 Authorities Patient Associations Learned Societies Unions Comparable Not comparable
32. 03/04/2016 32 STRATEGIC POSITIONING FOR ORIGINATORS Regulatory issues on the development of Biosimilars – Joseph Pategou
33. 03/04/2016 33 Sample of the Benchmarking Benchmarking  13 companies  From 2000 to 2015  Identify the strategic positioning of Originator manufacturers Face Biosimilars competition Company Product Glaxosmithkline Augmentin, Paxil, Amoxicilline Lilly Prozac Sanofi Cardizem Servier Périndopril Merck & Co Claritin Fournier Lipanthyl Astrazeneca Oméprazole Astrazeneca Merck-Lipha Glucophage MSD Inegy , Zocor Pfizer Gabapentine pfizer Amgen Neupogen Bristoll Myers Squibb Buspar Teva Simvastatine Teva Regulatory issues on the development of Biosimilars – Joseph Pategou
34. Price Patent Legal Action Cooperation Product Prescription Market Saturation New Market Environmental Strategy Brand Strategy 03/04/2016 34 The 10 levers of Originators to face Biosimilars 10 Levers 1 4 3 2 8 7 6 5 10 9 Regulatory issues on the development of Biosimilars – Joseph Pategou
35. 03/04/2016 35 Focus on Environmental Strategy Environmental Strategy 3 Actions:  Promote the obligation of the four-letter code (BQ) at the end of the name of Biosimilars  Promote for the Biosimilar a different Summary of Product Characteristics (SmPC) from the Generics and Originators  Promote the substitution of Biosimilars by physicians All this will contribute to highlight that biosimilars unlike generics are not identical to originators, but different products 9 BQ: Biological Qualifier Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview
36. Brand Strategy 2 Actions:  Create more adhesion of patients and healthcare professionals to their drugs (adhesion to the brand)  Bring more services to patients and healthcare professionals on their drugs (For example monitoring)  Example: Amgen’s Evaluation of personalized patient counseling for Enbrel  Phase IV trial with 300 patients with RA  Patient adherence and persistence to therapy in chronic disease  Justify a premium price for Enbrel over Biosimilars 10 03/04/2016 36 Focus on Brand Strategy Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview RA: Rheumatoid Arthritis
37. 03/04/2016 37 Key Learning Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview  No Single but Combination of Strategy  No Global but Glocal Strategy  Example: Neupogen, Amgen
38. 03/04/2016 38 Regulatory issues on the development of Biosimilars – Joseph Pategou Source: Interview Localization Neupogen Amgen Global USA Mature Market Emerging Market Patent Legal Action • Cooperation • New Product • Market Saturation New Market Combination and Glocal Strategy 4 Locations for 6 Strategies LIEN HYPERTEXTE
39. 03/04/2016 39 Conclusion: Regulatory issues on the development of Biosimilars – Joseph Pategou  Reduction of health spending in OECD countries  Clear difference between Biosimilars and Generics  EU: the most advanced market for Biosimilars  Substitution and interchangeability are great issues for all actors  Germany: the most favorable regulation for Biosimilars  Regulation issues on Biosimilars evolve quickly  10 levers of Originators to face Biosimilars
40. 03/04/2016 40 THANK YOU FOR YOUR ATTENTION Regulatory issues on the development of Biosimilars – Joseph Pategou
41. 03/04/2016 41 APPENDIX Regulatory issues on the development of Biosimilars – Joseph Pategou
42. 03/04/2016 42 THE 10 LEVERS: Comparison of levers used to face Biosimilars and Generics Levers Biosimilars Generics Price X X Patent X X Legal Action X X Cooperation X X Product X X Prescription - X Market Saturation - X New Market X -  Common points between strategy to face the Biosimilars and Generics competition Regulatory issues on the development of Biosimilars – Joseph Pategou
43. 03/04/2016 43 Price Regulatory issues on the development of Biosimilars – Joseph Pategou 1 866,08 € 858,47 € 858,47 € 749,01 € 746,17 € 691,91 € 688,28 € 703,74 € 700,89 € 0 300 600 900 2006 2008 2009 2012 2015 Price (euro) NEUPOGEN 48 MU (0,96 MG/ML) TEVAGRASTIM 48 MUI/0,8 ML Graph 23: The evolution of Neupogen and Tevagrastim price over 2006-2015
44. 03/04/2016 44 Cooperation Regulatory issues on the development of Biosimilars – Joseph Pategou 4 The company’s CEO Kevin Sharer stated in January 2011 that in order to drive growth, the company was going to consider entering the biosimilars sector but “in a controlled way,” (Beasley, 2011). In December 2011, Amgen announced it had signed a deal with Watson to develop and commercialize a number of oncology biosimilar monoclonal antibodies (MAbs). Under the agreement, Amgen will be primarily responsible for developing, manufacturing and initially commercializing the products, while Watson will put in up to $400m in co- development costs and will share product development risks. Biosimilars from the collaboration are expected to be sold jointly by both companies. Amgen has secured a clause which prevents the collaboration from making biosimilar versions of its drugs including Enbrel (etancercept), Aranesp (darbepoetin alfa) and Epogen (epoetin alfa). This deal gives the opportunity to Amgen to enter the biosimilars arena, to develop his know how and to know more how his can protect his product, Neupogen.
45. 03/04/2016 45 Prescription Regulatory issues on the development of Biosimilars – Joseph Pategou 6 Prescription The new European regulations promote this strategy by granting one year additional exclusivity for products that laboratories decided to switch to OTC. Pharmaceutical laboratory make the drug available without a prescription and bet on attachment to the brand. The Claritin (loratadine ) medicine of the laboratory MSD became OTC in the United States in November, 2002. Generic version entered on the market in the end of December, 2002.
46. 03/04/2016 46 The evolution of sell of Neupogen from 2008 to 2014 Regulatory issues on the development of Biosimilars – Joseph Pategou 1,4 1,2 0 0,4 0,8 1,2 2008 2014 Billion $ Sales of Neupogen
47. 03/04/2016 47 GLOBAL ECONOMIC SITUATION: Reduction of health spending Regulatory issues on the development of Biosimilars – Joseph Pategou
48. 03/04/2016 48 Anti-TNF, Insulins and Onco MABs are the key biologics Source: IMS Regulatory issues on the development of Biosimilars – Joseph Pategou
49. 03/04/2016 49 NAMING Regulatory issues on the development of Biosimilars – Joseph Pategou
50. 03/04/2016 50 COMPARISON OF DIFFERENCE AND COMMON POINTS BETWEEN BIOSIMILARS AND GENERICS-STRUCTURE KEY POINTS BIOSIMILARS Generics Nature Drug extracted from a biological environment Chemical drug Molecular size Up to 270,000 Da 100 to 200 Da Development Comparative studies Bioequivalence studies Duration of development 5-7 years(500 patients) 2-3 years (20-50 patients) Cost of the development 200-300 million dollars 2-4 million dollars Regulatory issues on the development of Biosimilars – Joseph Pategou
51. 03/04/2016 51 TOP DRUG-PATENT EXPIRE Regulatory issues on the development of Biosimilars – Joseph Pategou
52. 03/04/2016 52 MARKET TRENDS: Global picture KEY POINTS DIFFERENCE IDENTICAL The leading countries x Market value x Number of product x Production cost x Comparison between Biosimilars and Generics Focus on EU :  Most advanced market  80% of global spending in 2011  11% of total biologics sales in 2011  50% of the off-patent biological market in 2020 Countries Sales in volume (M) Sales in value ( M€) Germany 6,1 68 France 2,7 40 Italy 2,5 22 UK 0,5 19 Biosimilars market in volume and value in 2011 Regulatory issues on the development of Biosimilars – Joseph Pategou Source: IMS
53. 03/04/2016 53 THE FUTURE BIOSIMILARS Regulatory issues on the development of Biosimilars – Joseph Pategou
54. 03/04/2016 54 BIOSIMILARS MARKET IN VOLUME AND VALUE Regulatory issues on the development of Biosimilars – Joseph Pategou
55. 03/04/2016 55 STRATEGIES OF PHARMACEUTICAL COMPANY TO PROTECT THE PLACE OF THEIR MEDICINE-(GENERICS) DCI Laboratory Name Patent Legal Actions Product Brand Strategy Amoxicilline- acide clavulanique Glaxo Smith-Kline X X X Buspirone Bristoll Myers Squibb X X Gabapentine Pfizer X X X Omeprazole Astra Zeneca X X X Regulatory issues on the development of Biosimilars – Joseph Pategou
56. 03/04/2016 56 MANUFACTURING OF BIOSIMILARS Un processus de fabrication en 6 étapes: Les biosimilaires sont composés de protéines recombinantes dont la fabrication se décline en 6 étapes. Chacune de ces étapes implique d’importants efforts en R&D et en contrôle qualité : les propriétés thérapeutiques des molécules dépendent fortement de leur processus de fabrication. 1. Sélection du gène et de la cellule-hôte 2. Création d’une culture cellulaire à partir d’une banque de cellules 3. Synthèse de la protéine recombinante par les cellules hôtes 4. Purification de la protéine synthétisée 5. Formulation du médicament 6. Conditionnement pharmaceutique Regulatory issues on the development of Biosimilars – Joseph Pategou
57. 03/04/2016 57 REFERENCE 1. http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html 2. Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS 3. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp 4. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 5. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 6. Shaping the biosimilars opportunity-december 2011 7. http://www.sante.gouv.fr/qu-est-ce-qu-un-generique.html 8. Rapport 2012 sur les médicaments génériques-Mutualité Française 9. EMA Procedural advice for users of the centralized procedure for generic/hybrid applications 10. Lessons learned from the review of the labelling of 5 centrally authorised pandemic vaccines- 10 February 2014 EMA 11. Rapport 2012 sur les médicaments génériques- Mutualité Française 12. http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration 13. http://ec.europa.eu/health/authorisation-procedures_en.htm 14. Guideline on the investigation of bioequivalence- London, 20 January 2010- European Medicines Agency 15. http://www.australianprescriber.com/magazine/26/4/article/712.pdf 16. Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC 17. Biosimilars Marketing Authorisation status as of January 2013: 22 Marketing Authorisation Applications 18. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp 19. Individual case safety report: Article 28 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 20. Biological Qualifier An INN Proposal-July 2014- World Health Organization, Geneva 21. http://www.gabionline.net/Biosimilars/Research/Improved-labelling-sought-for-biosimilar-acceptance 22. EC consensus paper 2013- What you need to know about Biosimilar Medicines 23. European Commission consensus paper 2013 : What you need to know about biosimilar medicines 24. http://gabionline.net/Biosimilars/General/Germany-wants-to-increase-biosimilars-penetration 25. http://gabionline.net/Biosimilars/Research/Extrapolation-for-biosimilars 26. Directive 2001/83/CE du parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain 27. Where the opportunities are and what role will they play? EGA Lisbon 2011-IMS 28. http://healthcare.blogs.ihs.com/2012/01/06/generic-drug-price-trends-france-germany-italy-spain-uk/ Regulatory issues on the development of Biosimilars – Joseph Pategou
58. 03/04/2016 58 REFERENCE Regulatory issues on the development of Biosimilars – Joseph Pategou
59. 03/04/2016 59 REFERENCE Regulatory issues on the development of Biosimilars – Joseph Pategou
60. 03/04/2016 60 QUESTIONS FOR THE INTERVIEWS 1. Generally, a comparison is made between Biosimilars and Generics in terms of regulation, market penetration and sales. According to you, what are the aspects of Biosimilars comparable to Generics, and which ones are not? 2. In Europe, Germany is the largest market for Biosimilars. According to some, this advance may be explained partly by price regulation and Biosimilars repayment terms in Germany. In your opinion, what is the role of regulation in the European market for Biosimilars? 3. The name of a medication is an important element. It allows their differentiation and reassure patients. Regarding Biosimilars, the World Health Organisation has chosen to develop a four-letter code at the end of the name (for instance: epoetin alfa bbbb). This code is entitled to differentiate Generic and Originators from Biosimilar. What do you think of this approach? 3.1 Some professionals believe that this differentiation will hamper the substitution needed to reduce health care costs. What is your opinion? 3.2 Will this naming system allow to more easily track the adverse effects that could be included in the patient records? 3.3 Do you think of other advantages or disadvantages related to this approach? 4. Instructions accompanying medication provides important information for its proper use and for patient safety. Do you think the instructions of a Biosimilar should provide the same information as the ones of the Generic or Originators it replaces? 4.1 In order to strengthen trust, some associations recommend a combination of information about each Biosimilar and the reference product in the record. What is your opinion regarding this proposal? 4.2 Will not a different instruction between the Biosimilar and reference lead the prescriber to the conclusion that Biosimilars do not require the same level of proof that their reference products? 4.3 Do you see other advantages or disadvantages in the fact of differentiating instruction of a Biosimilar from the one of its reference product? Regulatory issues on the development of Biosimilars – Joseph Pategou
61. 03/04/2016 61 QUESTIONS FOR THE INTERVIEWS 5. Some reference products already commercialised are used in several therapeutic indications. Regarding Biosimilars, is such a use desirable? 5.1 If extrapolation is desirable, is conducting a clinical study necessary? 5.2 If not, is it necessary to implement the same approach, which is used for Generics? (Meaning setting up bioequivalence studies?) 6. In France, Italy, and in Germany, the replacement of a medication by a Generic is possible through a pharmacist. Do you think that this process should be extended to Biosimilars? 6.1 In your opinion, is replacement by Biosimilar not going to threaten medication’s traceability, and thus the identification of the origin of undesirable reactions in the patient? 6.2 The process of substitution requires the creation of a regulatory basis for interchangeability criteria. Do the expected benefits of such regulations allow you to justify the costs and regulatory risks borne by the stakeholders (government and companies)? 7. In Germany, in some cities such as Bremen, a quota system encouraging doctors and health insurance fund to use Biosimilars has been set up. It is translated into an increase in the prescription of Biosimilars in this town. What is your point of view regarding the set-up of quotas or call for tender for Biosimilars? 7.1 As part of a call for tender, if a company wins a two-year contract, there is little incentive for competitors to produce. If the provider chooses not to meet its obligations, there is a risk of supply disruption. Do you think that it is a major issue in your country? What would you consider the best way to prevent this situation? 7.2 In order to improve the penetration of Biosimilar in various countries, would not it be more effective to communicate to physicians and suppliers about the high quality standards for Biosimilars? What would be according to you the best way to answer it? Regulatory issues on the development of Biosimilars – Joseph Pategou
62. 03/04/2016 62 QUESTIONS FOR THE INTERVIEWS 8. In 2013, on the world scene the Biosimilars market accounted for $ 1.3 billion of which 80% in Europe. By 2020 it will account for $ 25 billion. According to you, what will be the evolution of this market in the upcoming years in Europe, especially in France, Germany, Italy and in the United Kingdom? 9. The introduction of Generics has significantly reduced medication prices. For instance, in Germany the decrease can reach of 71%. Regarding Biosimilars, may we expect such a decrease? 10. With Biosimilars and Generics being present on the market, do you think that Originators medications will keep their leadership in France, Germany, Italy and in the United Kingdom? Regulatory issues on the development of Biosimilars – Joseph Pategou