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EBR_October-15_pp.30-34 (Molekule)

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EBR_October-15_pp.30-34 (Molekule)

  1. 1. 30 Market Focus: Biosimilars October 2015 Window of Opportunity With the patent cliff on the horizon, the robust adoption and uptake of biosimilars is widely anticipated, due to their comparable efficacy and safety to reference biologics, and their meaningful pharmacoeconomic benefits to patients, payers and healthcare systems David Alderman at Molekule Consulting Many genericised small molecule pharmaceuticals are considered therapeutically equivalent,relative to their reference-listed drug.In these instances,both the reference product and its generic counterpart are bioequivalent and pharmaceutically equivalent.Generally,bioequivalent generic molecules can be substituted at the dispensing pharmacy level; in the US,therapeutically equivalent generic assets are given an AB rating by the FDA. Large molecules – also known as biologic pharmaceuticals – are differentiated from small molecules,as no two large molecule assets are exactly the same.Given the impossibility of having two identical biologic drugs, therapeutically equivalent large molecules are called biosimilars (see Figure 1). Regulatory Policy On the whole,many countries do not have official regulatory recommendations for large molecule interchangeability.However,in the US, an official interchangeability designation is allowed for large molecule therapeutically interchangeable biologics.These requirements are distinct from biosimilar guidance.It is postulated that methodical and rigorous clinical study will be required to confer the designation. Furthermore,different biosimilar regulatory schema and rigours are applied by the EMA and FDA (see Figure 2). However,despite distinct regulatory pathways for the approval of biosimilars, the overall scouting and development Cross reference Europe – EMA Decisions on substitutions are made at national level. In many EU countries, automatic substitution of biologics is officially prohibited or not recommended. WHO The WHO does not define standards on interchangeability for biologic medicines. It recognises that a number of issues associated with the use of biologics should be defined by national authorities. Figure 1: Substitution and interchangeability – at a glance Figure 2: Due to the varied nature of biotechnology products and their potential risks, manufacturers of both innovator biologic medicines and biosimilars are required to submit pharmacovigilance and risk management plans as part of their application US – FDA The FDA can designate a biosimilar as an interchangeable biologic when the following criteria are met: 1. The biologic product is biosimilar to the reference product; and 2. It can be expected to produce the same clinical results as the reference product in any given patient; and 3. For a biological product that is administered more than once to an individual, the risk in terms of safety of diminished efficacy or alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alteration or switch US EU Key: S&E – Safety and efficacy Clinical pharma – Pharmacokinetics/ Pharmacodynamics Originator Clinical S&E Clinical pharma Non-clinical Quality Originator Clinical Non-clinical Quality Biosimilar Clinical S&E Clinical pharma Non-clinical Quality Biosimilar Clinical Non-clinical Comparability data Quality
  2. 2. www.samedanltd.com32 the financial commitment to developing an originator large molecule is greater than $800 million,whereas a biosimilar development programme costs approximately $100-200 million. Biosimilar developers and marketers argue that their respective assets offer comparable efficacy and safety to the reference-listed innovator biologic at a relatively reduced cost burden to patients, payers and the overall healthcare system. This value proposition is predicated on health/pharma economic considerations correlating with key regulatory wins and data extrapolation in select global biosimilar scenarios. Player Competition Pharma players have a relatively reduced cost of goods sold for their respective biosimilar assets,compared with innovater reference-listed biologics. As such,from a commercial and marketing standpoint,a significantly competitive field is emerging – both biosimilar versus biosimilar competition and biosimilar versus innovator competition.Developers must assert aggressive and potentially asymmetric marketing,contracting and manufacturing strategies,in addition to tactics and initiatives to win in this emerging space. On top of this,innovator companies must be prepared to aggressively defend their respective proprietary large molecule biologics against impending biosimilars. Irrespective of whether it is a biosimilar or ethical biologic marketer,key success factors (KSFs) must be established to align positive outcomes in light of competing biosimilar entries.The approach to commercial success will vary depending on the product,country and channel sought,both from an offensive – biosimilar go-to-market – and defensive – ethical biopharmaceutical market defence – perspective (see Figure 5). On the Market In the biosimilars space,there is a robust and increasing opportunity for high- quality biopharma players to develop and enter newly charted waters.Between 2016 and 2018,some $37 billion worth of process remains highly similar across most regulated global markets (see Figure 3). Cost Savings Currently,the biosimilar opportunity represents a core,future-orientated growth driver among traditional pharma players,as well as multinational ethical biopharma parties.Citing significantly lower R&D costs,and an expedited clinical development timeline to potential marketability,biosimilar developers are keen to invest heavily in the biosimilarisation of blockbuster large molecule biologics (see Figure 4). The cost savings can be substantial; Proprietarybiologicbrand Approach for commercial success varies significantly by product, country and channel sought Need to focus resources on highest impact areas, given typically lower investments than originator biologic molecules Successful commercial model can range from tender management to a fully branded approach KSFs Country X/Product X Country Y/Product Y Promotional activities (for example, materials, field representatives) Key account management Tender management Market access Medical science liaisons Patient kits/training Key: Not a major KSF Major KSF Figure 3: The value chain journey from biosimilar asset opportunity scouting to go-to-market launch is rigorous and methodical Figure 4: An expedited R&D pathway; biosimilar development juxtaposed with reference biologic development Figure 5: KSFs for commercialisation activities should be employed to maximise biosimilar penetration on a global scope and scale Revenue Source: Molekule Consulting, 2015 Biosimilar 1 2 3 4 5 6 7 8 9 10 11 12 Biosimilar player targets proprietary product for development Reference biologic >$800 million From cell to biosimilar product Biosimilar: $100-200 million Discovery Preclinical Phase 1 Phase 2 Phase 3Dev Dev Preclinical Phase 1 Phase 3 Ethical biological agent’s patent expiry Biosimilar player files regulatory dossiers in support of biosimilar assets Biosimilar competitors launch biosimilar equivalent of branded biologic asset Time
  3. 3. www.samedanltd.com34 Biosimilar players needing to expand and upgrade their technical and manufacturing operations and facilities in order to sufficiently meet market demand and avoid early-stage product stockouts In conclusion,the biosimilar opportunity is robust,growing and sustainable. However,given multiple market factors – including a lack of consumer and prosumer biosimilar knowledge,fierce competition and innovator companies’ desire to defend their proprietary biologic assets – biosimilar market uptake and adoption may be slow and irregular until a critical mass effect is achieved. drugs will lose their intellectual property protection and these assets will be open to immediate biosimilarisation (see Figure 6).Nonetheless,despite these massive potential revenue streams, it is postulated that biosimilars will not achieve a critical mass and market uptake until 2023-2025. In March 2015,Sandoz,the generics and biosimilars arm of Novartis,received FDA regulatory approval for Zarxio,a biosimilar version of Amgen’s Neupogen. However,pursuant to legal proceedings and injunctions filed by Amgen,there was a six-month delay to Zarxio’s US market launch.Four additional regulatory applications have been filed with the FDA this year,indicating the critical pace and strategic importance of biosimilars to the market,as well as their respective developers and marketers. Slow Steps A number of factors,including the Zarxio legal precedent,may temper biosimilar market adoption and growth until a true understanding and prescriber buy-in is achieved.Specifically,market factors impacting and potentially limiting biosimilar adoption include: Patient,physician and payer-level pause and concern regarding switching established biologics patients to biosimilars,with possible substituting and conversion issues Global regulatory uncertainty regarding biosimilar interchangeability Slow response from prescriber and payer-level early adopters for bio-naïve patients Innovator biologics companies aggressively defending their intellectual property and large molecule biologic assets via strategic and tactical blocking and tackling of biosimilars David Alderman is President of Molekule Consulting, a global competitive intelligence-focused management consultancy. Recognised as a biopharma subject-matter expert with an in-depth understanding of biosimilars and generics, as well as multiple disease states, current and future market players, and developmental pipeline compounds, David provides actionable strategic advice to leaders in the sector. He has completed further education in Genetics and Molecular Biology and did his academic and research training at Columbia University College of Physicians and Surgeons, and Emory School of Medicine, US. Email: dalderman@molekuleconsulting.com About the author Figure 6: Estimated sales of products losing US patent protection during the year prior to patent expiry in US $ billions Past Present Forward looking Asset class 2013 2014 2015 2016 2017 2018 Total Biologics 10 7 25 14 3 20 79 Inhalers 0 5 2 7 1 4 19 Injectables 3 3 8 1 5 1 21 Ophthalmics 1 3 1 5 Transmucosals 1 1 2 Topicals 0.5 0.1 0.2 0.1 1 Intranasals 1 0.2 1 Transdermals 1 1 Oral solids 14 16 22 15 11 10 88 Total 29 36 59 37 20 36 217 Binary opportunities Missed opportunities (if not currently invested) Steady opportunities Source: Evaluate, 2013; McKinsey Analysis, 2013 Market value opportunity Low High

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