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Biosimilar drugs in europe threat or opportunity to innovation -- toc, exec summary and sample pages Document Transcript

  • 1. November 2011Biosimilar Drugs in Europe:threat or opportunity to innovation?A FirstWord ExpertViews Report
  • 2. Biosimilar Drugs in Europe: threat or opportunity to innovation?Biosimilar Drugs in Europe:threat or opportunity to innovation?Published November 2011© Copyright 2011 Doctor’s Guide Publishing LimitedAll rights reserved. No part of this publication may bereproduced or used in any form or by any means graphic,electronic or mechanical, including photocopying,recording, taping or storage in information retrievalsystems without the express permission of the publisher.This report contains information from numerous sourcesthat Doctor’s Guide Publishing Limited believes to bereliable but for which accuracy cannot be guaranteed.Doctor’s Guide Publishing Limited does not acceptresponsibility for any loss incurred by any person whoacts or who fails to act as a result of information publishedin this document. Any views and opinions expressed bythird parties and reproduced in this document are notnecessarily the views and opinions of Doctor’s GuidePublishing Limited. Any views and opinions expressedby individuals and reproduced in this document are notnecessarily the views and opinions of their employers.
  • 3. Biosimilar Drugs in Europe: threat or opportunity to innovation?ContentsExecutive summary .................................................................................................................................. 1Biosimilar drugs in Europe ................................................................................................................... 2What are biosimilars?.............................................................................................................................. 2 Generics and biosimilars – similarities and differences ................................................................................ 3 Biosimilars available so far in Europe .......................................................................................................... 5The market opportunities for biosimilars in Europe................................................................... 7 The biologics patent cliff will have an impact on the market ........................................................................ 7 Market types for biosimilars will differ across Europe ................................................................................. 9 Geographic markets for biosimilars will vary across Europe ................................................................... 9 In Italy, prescriptions are fulfilled by brand ....................................................................................... 10 In France and Spain, drugs are discounted to targets ..................................................................... 10 In the UK, biosimilar uptake is driven by NICE ................................................................................ 10 In Germany, biosimilars uptake is good but varies by drug type ...................................................... 11 Biosimilar uptake will vary by molecule and indication across Europe.................................................. 11 Epoetin uptake may have been slowed by immunogenicity issues ................................................. 11 Filgrastim uptake has been faster in Europe.................................................................................... 12 Biosimilar use is likely to vary between chronic and episodic treatment ............................................... 12 There may be a resistance to switching patients on established treatments ........................................ 12 Hospital physicians may be more likely to use biosimilars than primary care physicians ..................... 13 Biosimilars will have an impact in cost-sensitive markets ..................................................................... 13 The paediatric population may be reluctant to take up biosimilars ....................................................... 14The challenges for biosimilars in Europe ..................................................................................... 15 The biosimilars challenge: Gaining approval in Europe ............................................................................. 15 The EU regulatory process for biosimilars ............................................................................................ 15 Biosimilar regulations will be a steep learning curve ............................................................................. 16 Will regulations be fair and balanced on all points? .............................................................................. 17 The biosimilars challenge: Overcoming development and manufacturing hurdles .................................... 18 Biologics are highly variable by nature .................................................................................................. 19 Variations can cause issues with immunogenicity................................................................................. 19 The biosimilars challenge: Overcoming patent hurdles.............................................................................. 21 The biosimilars challenge: Gaining stakeholder trust ................................................................................. 21 Payers can be a major driver for biosimilars uptake ............................................................................. 21 Physicians will be key gatekeepers for biologics and biosimilars.......................................................... 22 Patients may be cautious about biosimilars .......................................................................................... 22The defensive position: Originator companies will try to limit biosimilar uptake ....... 23 Lifecycle management can maintain market share .................................................................................... 23 Lack of automatic substitution will protect originator drugs ........................................................................ 23 Exclusivity provisions and patents will protect originator drugs.................................................................. 25 Originator companies can exploit loyalty to maintain market share ........................................................... 25All Contents Copyright © 2011 Doctor’s Guide Publishing Limited. i www.fwreports.com November 2011All Rights Reserved
  • 4. Biosimilar Drugs in Europe: threat or opportunity to innovation? Focusing on quality, safety and efficacy claims can maintain loyalty .................................................... 26 Using marketing, sales and healthcare professional training to attract and keep market share ........... 27 Protecting the market through degree of similarity – is a biosimilar really similar? .................................... 27 Competitive pricing and rebate agreements will keep cost-sensitive customers ....................................... 27The offensive position: breaking into a new market ................................................................ 28 Pricing is the key differentiator for biosimilars ............................................................................................ 28 Knowing the market will help gain market share ........................................................................................ 29 Information and education: defending biosimilars against the naysayers .................................................. 30 Sales, marketing and account management: Market share through talking to the payers ................... 30 Education for healthcare professionals: Market share through talking to the physicians ...................... 31 Gaining market share by adding value: Devices and formulations ............................................................ 31 Making the biosimilar easier to use: Devices ........................................................................................ 32 Making the biosimilar easier to handle: formulations ............................................................................ 32 Protecting biosimilars through patents ....................................................................................................... 32The company landscape: Opportunities for companies in biosimilars............................ 33 Generics companies will be key players .................................................................................................... 34Collaboration and licensing in the biosimilars market ............................................................ 35 Collaborations between generics companies – bringing together development and marketing ................ 35 Collaborations between generic and originator companies combines know-how and manufacturing capabilities.................................................................................................................................................. 35 Geographic collaborations allows access to wider markets ....................................................................... 36 Looking into biosimilars deal data .............................................................................................................. 36 Biosimilar deals by volume .................................................................................................................... 36 Biosimilar deals by value ....................................................................................................................... 38 Biosimilar deals by type......................................................................................................................... 38 Biosimilar deals by indication ................................................................................................................ 38 Biosimilar deals: Deal case studies ............................................................................................................ 39 Biopharma company signs agreement to access biosimilars................................................................ 39 Generics company signs agreement to fill pipeline ............................................................................... 40What’s next for biosimilars in Europe? .......................................................................................... 41 Monoclonal antibodies will be a dramatic entry to the biosimilars market .................................................. 41 Biobetters could ‘follow-on’ from biosimilars............................................................................................... 41 Biobetters will follow a different route of approval ................................................................................. 42 The US: Changing the biosimilars environment ......................................................................................... 42Conclusion ................................................................................................................................................44Acknowledgments .................................................................................................................................. 45Bibliography ..............................................................................................................................................46All Contents Copyright © 2011 Doctor’s Guide Publishing Limited. ii www.fwreports.com November 2011All Rights Reserved
  • 5. Biosimilar Drugs in Europe: threat or opportunity to innovation?Executive summary and efficacy data, using marketing, sales and healthcare professional training, and looking atn Biosimilars are therapeutically similar copies new pricing models. of biological therapeutic reference drugs n The lack of automatic substitution has potential (therapeutics derived from living organisms), to limit biosimilar market share. developed after the patent on the originator drug (reference product) has expired. n Biosimilar companies will work hard to break into this new market, through using pricing o A range of blockbuster biologic patents are as a key differentiator. They will need to learn due to expire between now and 2019. the market and work with physicians to createn Biosimilars have been available in Europe loyalty to the new biosimilar brand, exploiting since 2006, and 14 have been approved to physicians’ familiarity with small molecule date. generics, as well as adding value by creating new delivery devices, formulations and sizes.n The biosimilars market could be worth $2.25-4.8 billion by 2015, and this is a major n The biosimilars market will be an opportunity opportunity for companies entering this arena. for existing generics companies and originator companies looking to move into new markets.n Biosimilar markets will vary across Europe – Germany is already a major European n Monoclonal antibodies and biobetters will be biosimilars market – and pricing and the next step for the biosimilars market. reimbursement will vary in different countries, n When the US route of approval is clarified, this and even across individual countries. will mean a major expansion for the biosimilarsn Biosimilar markets will also vary by molecule market. and indication, with filgrastim already having a faster uptake than epoetin.n Biosimilar uptake will also vary by setting - Generic Substitution: Taking a hospital or primary care – but this may change Narrow View? examines the trend as cost-cutting continues in healthcare. towards generic substitution in majorn Biosimilars companies will face challenges, markets—and why a similar practice particularly because biologics are variable with narrow therapeutic index drugs is by nature – gaining approval, managing the drawing fire potential risk posed by new biosimilars post- approval, and creating new manufacturing processes around the barriers posed by the originators’ patents.n Biosimilars companies need to gain stakeholder trust, because the stakeholders will drive biosimilars uptake.n The originator companies will want to retain market share, and they may take a number of different approaches, such as using lifecycle management, building on physician loyalty through focussing on existing quality, safetyAll Contents Copyright © 2011 Doctor’s Guide Publishing Limited. 1 www.fwreports.com November 2011All Rights Reserved
  • 6. Biosimilar Drugs in Europe: threat or opportunity to innovation?Table 1: Proposed definitions Term(s) Definition Implications Biosimilar Copy version of an authorized Only very small differences with no biologic with demonstrated similarity clinical relevance in physicochemical characteristics, Extrapolation of clinical indications efficacy and safety acceptable if scientifically justified Me-too or non- Biologic developed independently and May have physicochemical differences innovator biologic not directly compared to or analyzed compared with other biologics in same against a licensed reference biologic product class May or may not have been compared Clinical comparison may not pick up clinically potentially relevant differences Extrapolation of clinical indications may be difficult Second-generation Structurally and/or functionally altered Usually stand-alone development with a or next-generation biologic to improve or change clinical full development programme biologic or biobetter performance Clear differences in structure Likely to have different clinical behaviour Claims would have to be supported with data showing a clinically relevant advantage Source: Based on Weise et al.3In order to clarify things, the Biosimilar Generics and biosimilars –Medicinal Products Working Party (BMWP) at similarities and differencesthe EMA created some proposed terminology.Published in Nature in 2011, this defined a The term ‘generic’ is generally used to refer to abiosimilar as “a copy version of an already small molecule generic medicinal product referenceauthorized biological medicinal product with drug. The UK Medicines Amendment Regulationsdemonstrated similarity in physicochemical 2005 define a generic medicinal product as onecharacteristics, efficacy and safety, based on a that “has the same qualitative and quantitativecomprehensive comparability exercise.” 2 See composition in active substances and the sameTable 1 for further proposed definitions. pharmaceutical form as the reference medicinal product and whose bioequivalence…has been demonstrated.”4 There are significant Small molecule generics can be approved for the differences between biosimilars and market in Europe based on pharmacokinetic and small molecule generics (and their reference molecules) 3 Weise, Bielsky, De Smet, Ehmann, Ekman, Narayanan, Heim, Heinonen, Ho, Thorpe, Vleminckx, Wadhwa and Schneider Biosimilars - why terminology matters.2 Weise, Bielsky, De Smet, Ehmann, Ekman, Narayanan, 4 WilmerHale. (December 1, 2005). UK Medicines LegislationHeim, Heinonen, Ho, Thorpe, Vleminckx, Wadhwa and Assists Generic Competition. http://www.wilmerhale.com/Schneider Biosimilars - why terminology matters. publications/whPubsDetail.aspx?publication=2976.All Contents Copyright © 2011 Doctor’s Guide Publishing Limited. 3 www.fwreports.com November 2011All Rights Reserved
  • 7. Biosimilar Drugs in Europe: threat or opportunity to innovation? Another of the drivers is the reputation of the “The German government has companies within Germany. The companies been pro-biosimilar since biosimilars behind biosimilars are well known and trusted, for reached the market” example Ratiopharm. Duncan Emerton, Head of Biosimilars, “Ratiopharm as a corporate brand is one of the Datamonitor Healthcare Consulting most trusted brands in Germany, up there with BMW and Mercedes, with both the general publicIn Germany, biosimilars uptake is good but and physicians, and has been providing genericvaries by drug type products to the German health service for a number of years. The reputation and the ability toThe uptake of some biosimilars in Germany has convince key stakeholders have translated overbeen good, with 60 percent of the epoetin market to the biosimilar space, and this was one of theshare being filled by biosimilars. However, the key drivers of Teva’s acquisition of Ratiopharm,”biosimilar share of the growth hormone market says Emerton.in Germany is only four percent, which highlightsthat the uptake of biosimilars will be highly variable Biosimilar uptake will vary by moleculeacross product types24. One of the drivers is the and indication across EuropeGerman government, which has encouraged the use Since the launch of the first biosimilar in 2006,of biosimilars, and has quota requirements25. These there has been variation in the uptake of differentdiffer between drugs and across Germany – the biosimilars across Europe.quotas for biosimilar epoetin as a percentage of allprescriptions of epoetin, for example, range from 20percent in Hamburg to 40 percent in Berlin26. Epoetin uptake may have been slowed by immunogenicity issues“The German government has been pro-biosimilar Immunogenicity concerns associated with ansince biosimilars reached the market back in 2006. originator epoetin following a manufacturingThe biosimilar epoetins and G-CSF have done well change (see ‘Variations can cause issues within this market,” says Emerton. immunogenicity’) may have slowed the uptake of“Germany is one of the leading countries in terms of biosimilars in this molecule type and indication.penetration for the epoetins. This has been driven by The initial biosimilar epoetins approvals wereregional biosimilar quotas at the local level in Germany also not licensed for subcutaneous use –– of all the epoetins that are used in certain regions, associated with immunogenicity – limiting theira certain proportion is required to be biosimilars” says use across indications.Greenland. “As a result, the penetration of biosimilar “When the first two biosimilar epoetins wereepoetins in Germany has been quicker and higher approved in 2007, they did not have a licencethan for most other European countries. Now that for subcutaneous use, because this licence hadbiosimilars have been used for nearly four years in been taken away from the reference product,Germany, physicians are much more comfortable with Eprex, following the manufacturing change andusing biosimilars in patients in the same way that they immunogenicity concerns,” says Greenland. “Thiswould use the originators.” slowed uptake and although the caution from physicians was understandable the problems had24 Senior, M. (April 18, 2011). The IN VIVO Blog: Biosimilars:Dead Before They Really Got Started? http://invivoblog.blogspot.com/2011/04/biosimilars-dead-before-they-really-got.html.25 GaBI. The market for biosimilars. Epoetin uptake may have been26 Rovira, Espín, García and Labry The impact of biosimilars’ slowed by immunogenicity issuesentry in the EU market.All Contents Copyright © 2011 Doctor’s Guide Publishing Limited. 11 www.fwreports.com November 2011All Rights Reserved
  • 8. Biosimilar Drugs in Europe: threat or opportunity to innovation? Cancer 2% 2% 2% Haematological disease 6% 29% Endocrine disorders 8% Infectious disease 8% Musculoskeletal disease Genitourinary disorders 15% Disease of the nervous system 27% Gastrointestinal disease Figure 3: Biosimilar deals 2002-2011 – deal indication Source: PharmaVentures’ PharmaDeals database Respiratory diseaseBiosimilar deals: Deal case studies Biopharma company signs agreement Biocon will carry out the clinical development, to access biosimilars manufacture and supply of the biosimilar insulin China and India have long had reputations for products. Pfizer will secure regulatory approval illegal copying, but both are moving into the in Europe and the US and launch the insulin mainstream of approved generics and biogenerics. products onto emerging markets by 2011, and In October 2010, Pfizer signed an agreement with Europe and the US in 2012 and 2015 respectively. Bangalore-based biotech company Biocon64. Biocon’s recombinant, or genetically engineered, Pfizer will pay an upfront payment of $200 million, insulin products are already approved in 27 and R&D and milestone payments of $150 million, countries in developing markets65. to have exclusive global rights to commercialize “Places like India and South Korea have been a number of Biocon’s biosimilar insulins and manufacturing biological products for some time, insulin analogues. Biocon will also receive royalty whether in a contract capacity or as manufacturing payments. Pfizer will have exclusive rights to sites of international companies. So they certainly commercialize Biocon’s drugs globally with certain have some of the expertise there,” says Coney. exceptions, such as Germany, India and Malaysia, where Biocon will have coexclusive rights. 65 Krauskopf, L. and Nagaraju, B. (2010, October 18). Pfizer to sell biosimilar insulins in Biocon deal. Reuters. Retrieved from http://in.reuters.com/article/2010/10/18/ 64 Attack of the biosimilars. idINIndia-52267720101018All Contents Copyright © 2011 Doctor’s Guide Publishing Limited. 39 www.fwreports.com November 2011All Rights Reserved
  • 9. Biosimilar Drugs in Europe: threat or opportunity to innovation?What’s next for biosimilars in Europe?The European biosimilars market is still very newand is changing as it is growing, particularly as the The European biosimilars marketbiologics patent cliff approaches and biosimilar is still very new and is changingmonoclonal antibodies hit the market. as it is growing, particularly as the“The biosimilars market is only five or six biologics patent cliff approaches andyears old. It’s still a nascent market, especiallycompared with the small molecule generics biosimilar monoclonal antibodies hitmarket, which has been around in a formal the marketcapacity since the mid-’80s, and it still has along way to go,” says Emerton. “I think the nextthree to five years are going to be critical, and internationally – while the development costs will bewill shape how the biosimilars market evolves high, the rewards will be significant.”into the future, driven by the next phase ofbiologics coming off patent, particularly the Coney supports this: “Even a comparatively smallmonoclonal antibodies.” share of the monoclonal antibody market would be worth hundreds of millions of dollars – even“I would expect that every biologic on the market blockbuster-type sales.”will at some point be the target of a biosimilarmanufacturer,” says Greenland. Biobetters could ‘follow-on’ from biosimilarsMonoclonal antibodies will be Biobetters can be defined as improved versionsa dramatic entry to the of currently available biologics, and may havebiosimilars market a better side effect profile, lower toxicity, longerA number of European monoclonal antibody patents half-life, reduced immunogenicity, improvedare due to expire, including Rituxan (rituximab) and efficacy or a different route of administration.Remicade (infliximab), both in 2014. Companies arealready looking at monoclonal antibodies (mAbs) These can be as a result of simple changes,as biosimilars – for example, Teva is developing such as more homogenous glycosylation, whicha biosimilar version of Roche’s Rituxan, as are improves the heterogeneity within a batch, orSandoz and Spectrum Laboratories66. differences in formulation, which could improve cold chain supply issues.The EMA adopted guidelines for mAbs early in 2011,but only expects two to three applications a year67. An example of a biobetter is Neulasta (pegfilgrastim), a pegylated version of Neupogen“Most of the interest at the moment seems to focus on (filgrastim), used to treat chemotherapy-inducedthe monoclonal antibodies, particularly trastuzumab neutropaenia. It has a longer half-life andand rituximab,” says Cox. “They are high value drugs improved dosing regimen, though the clinical outcomes are the same.66 GaBI. (April 29, 2011). Generics manufacturers andbiosimilars. http://www.gabionline.net/Biosimilars/News/Generics- Innovator companies can use biobetters as partmanufacturers-and-biosimilars. of their lifecycle management, for example by67 GaBI. (February 11, 2011). EMA adopts guideline on creating patentable forms of drugs that havebiosimilar monoclonal antibodies. http://www.gabionline.net/Guidelines/EMA-adopts-guideline-on-biosimilar-monoclonal- come off patent. Because biobetters are actuallyantibodies. new molecules, they are patentable provided theyAll Contents Copyright © 2011 Doctor’s Guide Publishing Limited. 41 www.fwreports.com November 2011All Rights Reserved