By Manfred Weiler and Angel Uriol
For the last few years, activities in biosimilar development have been focused on the “big six” top selling monoclonal antibodies worldwide: adalimumab (Humira), infliximab (Remicade), etanercept (Enbrel), rituximab (Rituxan/Mabthera), trastuzumab (Herceptin) and bevacizumab (Avastin). The later three play a significant role in treating oncology patients and top the list of the best-selling oncology treatments. Multiple clinical biosimilar programs are under way for these top biologics and some have already been submitted to EMA or U.S. FDA for approval (trastuzumab biosimilars by Mylan/Biocon, Celltrion, and Amgen; bevacizumab biosimilars by Amgen/Allergan; rituximab biosimilars by Sandoz and Celltrion).
While there is continued biosimilar development across all of the “big six,” future biosimilar opportunities will likely focus on the next wave of oncology products. Forward looking sales forecasts for 2022 and beyond predict new monoclonal antibodies with blockbuster status.[1] A FiercePharma report on the Top 15 cancer drugs in 2022 from earlier this year predicted Opdivo, Keytruda, Tecentriq, Darzalex, Perjeta and Gazyva will be in the Top 12. [2]
While the first four of these drugs have patent protection well beyond 2025 and biosimilar clinical programs might not be imminent, we expect to see pertuzumab and obinituzumab biosimilar programs kick off in the next few years. With limited short-term opportunities, focus may also shift to second tier molecules with predicted revenues of 800M to 2.5B USD, such as Yervoy (ipilimumab), Xgeva (denosumab), or Kadcyla (trastuzumab-emtansine).
This next wave of monoclonal antibody biosimilar oncology drugs will face even greater challenges when it comes to the selection of endpoints and sensitive patient populations. With more treatment options and more targeted therapies, future biosimilar clinical trials and research will be more complex both scientifically and operationally. This requires an in-depth understanding of the current and expected changes in standard of care in potential study countries, the local preference of chemotherapy backbone or co-medication, the reimbursement of the originators drugs, and the prevalence of certain genetic mutations and the impact of all of these factors on patient recruitment.
At Syneos Health, we leverage our biosimilar development experts and medical oncologists within our Biosimilars Consortium to bring our best clinical, regulatory, operational and therapeutic insights to our customers committed to developing the next generation of oncology drugs.
For more information about our Oncology clinical trials experience, click here.
For our Biosimilar clinical trials and research experience, click here.
[1] http://info.evaluategroup.com/rs/607-YGS-364/images/wp16.pdf
[2] http://www.fiercepharma.com/special-report/special-report-top-15-best-selling-cancer-drugs-2022
About the Authors
Manfred Weiler, Senior Vice President, Europe and Asia Pacific Business and Alliance Development, Syneos Health™
Manfred Weiler is a member of the CSO office, focusing on the establishment of cross-therapeutic platforms providing scientific and medical support for Syneos Health customers. He has established and leads the Syneos Health Biosimilar Consortium, a team of experts from all Syneos Health departments actively engaged in the development of biosimilars from regulatory consulting, market access consulting, clinical operations, therapeutic business units, and Real-World Evidence.
Manfred has held leading roles in the CRO industry in Business Development and Alliance Management for the last ten years. Before, he was responsible for strategy and marketing for Research and Development and QC testing services for pharmaceuticals/biopharmaceuticals. Overall, Manfred has worked in the Life Sciences industry for more than 20 years in strategy, sales and marketing. He holds a PhD in molecular biology from the University of Bonn, Germany.
Angel Uriol, Vice President, Clinical Development, Oncology
Angel Uriol has 21 years of clinical research experience and has played several roles in clinical trial management. Angel also has operations leadership experience in pharmaceutical companies and top tier contract research organizations (CROs). Angel has focused primarily in leading large global/multi-national Oncology studies and is the subject matter expert for Oncology Biosimilar Studies in the Syneos Health Biosimilars Consortium. Angel is a registered pharmacist and has a master’s in international relationships.
