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BIOSIMILARS for RHEUMATOID ARTHRITIS an Experienced Partner Can Foresee Your Biosimilar Development Challenges

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BIOSIMILARS for RHEUMATOID ARTHRITIS an Experienced Partner Can Foresee Your Biosimilar Development Challenges BIOSIMILARS FOR RHEUMATOID ARTHRITIS An Experienced Partner Can Foresee Your Biosimilar Development Challenges The market for the use of biosimilars in the treatment of rheumatoid arthritis is rapidly expanding as many high-profile therapies come off patent. Despite the increasing number of biosimilars, there remain clinical, regulatory and market access challenges for developers. RA BIOLOGIC PRODUCTS CURRENTLY TARGETED LIKELIHOOD OF PAYERS STEERING BY BIOSIMILARS IN DEVELOPMENT UTILIZATION TOWARDS BIOSIMILARS Target product Company Estimated number of biosimilars in All therapeutic areas 7.12 development globally Humira® AbbVie 13 RA 7.60 (adalimumab) ® Enbrel Amgen 6 Oncology 6.16 (etanercept) ® Remicade Merck/Johnson 13 0 2 4 6 8 10 (infliximab) & Johnson Likelihood of steering utilization ® Will not Very likely Rituxan Roche 35 steer utilization to steer utilization (rituximab) toward biosimilars toward biosimilars Source: Amgen 2015 Trends in Biosimilars Report Source: Covance Commercial Payer Survey 2013–2015 COVANCE: THE ONLY GLOBAL CRO WITH AN INTEGRATED APPROACH REGULATORY-COMPLIANT ANALYTICAL STRATEGIES FOR CELL BANKS, INTERMEDIATES, DRUG SUBSTANCES AND DRUG PRODUCTS Market Access to ► Analytical and stability assay development, qualification Proactive support product and testing to GMP standards regulatory dierentiation strategy and ► Assessment of biosimilarity to innovator drug, including agency characterization of process and analytical anomalies engagement CMC innovator ► Management of reference standards and antibody reagents and biosimilar ► Refinement of the analytical control strategy Expedited characterization Phase I and ► Process validation testing and linkage to product CQAs Phase III ► Validation to ICH requirements and cGMP standards clinical In vivo studies ► Manufacturing lot comparability testing studies ► Accelerated and long-term stability testing, including routine and global lot release to cGMP and ICH standards ► Monitoring and identification of data trends during commercialization SOLVING BIOSIMILAR CHALLENGES WITH COVANCE INTEGRATED DEVELOPMENT SOLUTIONS Covance has contributed to the development of 122 unique biosimilars in 217 individual projects since 2010, including 51 biosimilars directed against inflammatory targets (abatacept, adalimumab, aflibercept, belatercept, etanercept, infliximab, omalizumab, rituximab, tocilizumab, ustekinumab) Development challenges Covance solutions ► Efficiently demonstrating analytical ► Tailored CMC strategy around linking similarity to innovator biosimilar structure and function to likely CMC ► Applying most appropriate testing procedures clinical efficacy and risks to safety ► Competition to recruit required patients ► Database of >1,200 investigators who ► Low investigator and patient interest in have expressed interest in conducting biosimilar studies biosimilar studies ► Poor patient compliance ► Xcellerate® Trial Design leverages data in ► Poor patient retention in long studies the Covance clinical knowledgebase, which houses >40% of global trial data at any given time, providing the ability to locate high- performing investigators and target patient populations ► Strong relationship with the National Institutes of Health helps optimize recruitment and retention for studies based AND RETENTION in the U.K. PATIENT RECRUITMENT PATIENT ► Providing patients and caregivers with ongoing drug administration training ► Continued patient education, phone call/text appointment reminders ► High placebo response rates – ► Reducing eligibility creep via robust study up to 30% in RA design and specialist training of site staff, ► Subjective nature of trial outcomes, e.g., in ACR20 assessments e.g., PRO ► Using an ePRO device for direct data ► Variability in objective endpoint data, integration e.g., imaging ► Centralized assessment of imaging data DATA QUALITY DATA ► Lack of coherence between ► Early and frequent agency engagement regulatory bodies by our regulatory experts that each have up ► Rapidly changing guidelines to 30 years’ experience worldwide and strong relationships with the National Institute for Health Research (NIHR) Clinical Research Network REGULATORY ► Low acceptance of new biosimilars with ► Strategic planning from the early stages of key stakeholders development, considering all desired markets ► Challenging reimbursement policies ► Generating real-world evidence to prove ACCESS ACCESS MARKET value of biosimilar Covance has significant global experience employing realistic estimates, effective trial management and proactive risk mitigation to optimize your biosimilar drug development Learn more about our drug development solutions at www.covance.com Covance Inc., headquartered in Princeton, NJ, USA is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440 Europe / Africa +00.800.2682.2682 +44.1423.500888 Asia Pacific +800.6568.3000 +65.6.5686588 © Copyright 2018 Covance Inc. INFCDS003-0118.
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