Clarivate Plc · NYSE:CLVT
Clarivate — CPhI Biosimilar Webinar (October 2021)
25 slides from Clarivate's conference presentation, Oct 20, 2021
Slide 1: Biosimilars in Oncology
Biosimilars in Oncology Current Landscape and Future Possibilities in the U.S. and Europe Rachel Sliman, MPH October 20, 2021
Slide 2: Agenda
1. Introduction to Clarivate 2. Current Landscape of Biosimilars in Oncology 3. Access and Reimbursement 4. Drivers and Barriers to Uptake 5. Future of Biosimilars in Oncology 2
Slide 3: Clarivate
Clarivate (5 Clarivate”
Slide 4: Context Matters
Context Matters Key (Cortellis HTA Intelligence from 2022) questions • What are the key drivers of HTA decisions? Successfully negotiate pricing and reimbursement • What is the current HTA landscape for a to bring a new drug to market given indication? • Who are my current and future • Confidently p
Slide 5: Biosimilars
Biosimilars Key questions Size the opportunity in this lucrative market and evaluate the • What is the current and forecasted market landscape for various biosimilar disruptive effects of biosimilars molecules and their reference brand? • Assess the current and future market size for biosimilars acr
Slide 6: Current Landscape of Biosimilars in Oncology
Current Landscape of Biosimilars in Oncology 6
Slide 7: Biosimilar Approvals by Year
Biosimilar Approvals by Year Europe 14 • G-CSF and ESA biosimilars have been available for over a decade. 12 • The first oncology MAb biosimilars to launch in 10 Europe were the rituximab biosimilars Truxima in April 2017 and Rixathon in June 8 2017 2 10 FDA EMA 6 2 United States • September 2015, S
Slide 8: Biosimilar Approvals by Indication
Biosimilar Approvals by Indication Source: Context Matters Market Access Platform 16 14 12 7 10 4 8 6 3 6 FDA EMA 4 4 4 4 4 7 7 6 5 1 1 2 4 2 2 2 2 2 2 0 r r r r r r r ce ce LL ce ce m a ce H L LC ce ce n n C n n o n N C n n C a C a C a C a st C a N S C a C a l l la l st i c b y n a ca ct a tr io n
Slide 9: Access and Reimbursement in Biosimilars
Access and Reimbursement in Biosimilars 9
Slide 10: EMA and Biosimilars
EMA and Biosimilars • In 2005, the EMA became the first regulatory body to develop biosimilar guidance; • The EC has approved more than 50 biosimilars, 4 of which received approval in 2019 • Has had a centralized regulatory approval pathway for biosimilars in place since 2006. However, each European
Slide 11: FDA and Biosimilars
FDA and Biosimilars • March 2010 the United States enacted the Biologics Price Competition and Innovation Act (BPCI) • July 2018, the FDA published the details of the Biosimilar Action Plan. – The agency highlighted the plan’s aims to make the development and approval of biosimilars more efficient a
Slide 12: Drivers and Barriers to Uptake
Drivers and Barriers to Uptake A Study of Current Biosimilars Treatment in Oncology 12
Slide 13: The "Why" Behind Drivers and Barriers
The “Why” Behind Drivers and Barriers • This report is based on a 2020 survey of 180 oncologists in the United States, France, and Germany about their use of biosimilars in the oncology space. We also surveyed oncologists on this topic in 2018 and 2019, and we analyze the results across these survey
Slide 14: Q: What are the main drivers of biosimilar use
• Surveyed European and U.S. oncologists reported that lower cost (to payers, institution / clinics, and Q: What are the patients) is the main driver motivating them to main drivers of prescribe biosimilars. biosimilar use • After cost, physician familiarity / experience / i.e., motivate comfort wit
Slide 15: Drivers of Biosimilar Use: Medical Oncologists
ONCOLOGY CURRENT TREATMENT: BIOSIMILARS DECISION RESOURCES GROUP Drivers of Biosimilar Use: Medical Oncologists 25 Lower cost to payers 23 16 Physician familiarity/experience/comfort with 17 13 biosimilars 10 17 Lower cost to institutions or clinics 17 United States (n = 29) 11 16 Inclusion in treat
Slide 16: Drivers of Biosimilar Use: Hematologist-Oncologists
Drivers of Biosimilar Use: Hematologist-Oncologists 25 U U Lower cost to payers 27 8 24 Lower cost to institutions or clinics 25 17 16 Inclusion in treatment guidelines 15 United States (n = 30) 11 Physician familiarity/experience/comfort with 15 13 biosimilars 10 7 Endorsement by key opinion leader
Slide 17: Q: What do you believe are the main barriers
• Surveyed European and U.S. oncologists were mostly divided in Q: What do you their opinion on the barriers to believe are the biosimilar use. main barriers to biosimilar • 20-43% of U.S. and European use overall? physicians expect no barriers to biosimilar use in the future, reflecting their good
Slide 18: Barriers to Biosimilar Use: Medical Oncologists
Barriers to Biosimilar Use: Medical Oncologists Concerns about the lack of long-term clinical data/less data overall compared to brands 3 7 13 U Concerns about efficacy 9 1214 11 Switching from brand to biosimilar mid-treatment 10 10 Concerns about the quality of clinical data 6 10 11 7 10 United St
Slide 19: Barriers to Biosimilar Use: Hematologist-Oncologists
Barriers to Biosimilar Use: Hematologist-Oncologists Promotional efforts of brand manufacturers 24 11 G Insufficient cost benefit to healthcare system/payers 78 10 9 13 Concerns about efficacy 10 Concerns about the lack of long-term clinical data/less data overall compared to 8 11 brands 10 United S
Slide 20: The Future of Biosimilars in Oncology
The Future of Biosimilars in Oncology 20
Slide 21: Biosimilars Development Pipeline by Class
Biosimilars Development Pipeline by Class Oncology monoclonal Other antibody 27% 29% The classes of Infertility biologics most treatments 1% frequently targeted by biosimilar Parathyroid hormone developers are Mabs 1% (29%) used in Insulin 3% oncology and TNF-α inhibitors (11%) Ophthalmolo gy TNF-α
Slide 22: Top Biosimilar Development Projects by Reference Molecule
Top 10 Biosimilar Development Projects by Reference Mol bevacizumab • The top molecules most often targeted by trastuzumab biosimilars developers are adalimumab from the oncology and immunology therapy rituximab areas filgrastim – bevacizumab (Avastin), – trastuzumab (Herceptin), unspecified – adali
Slide 23: Oncology MAbs have a higher cost burden
• Cancer prevalence and treatment costs are increasing • Availability of biologic therapies to treat Oncology MAbs oncology disease conditions has led to improved clinical outcomes, have a higher • The high cost can create barriers and cost burden than disparities in treatment access, and MAbs in ot
Slide 24: Reports Referenced
Disease, Company & Drug Insights Reports Referenced • Current Treatment Physicians Insights Oncology US/EU October 2020 • Emerging Biosimilars • Access and Reimbursement: Biosimilars 24
Slide 25: Rachel Sliman, MPH
Rachel Sliman, MPH rachel.sliman@clarivate.com © 2020 Clarivate. All rights reserved. Republication or redistribution of Clarivate content, including by framing or similar means, is prohibited without the prior written consent of Clarivate. Clarivate and its logo, as well as all other trademarks use