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Granulocyte-Colony Stimulating Factor Biosimilars

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Granulocyte-Colony Stimulating Factor Biosimilars Granulocyte-Colony Stimulating Factor Biosimilars An Update for Frontline Oncology Practitioners This educational activity is jointly accredited for nurses and pharmacists and is supported by an independent educational grant from Pfizer, Inc. Faculty Sandra Cuellar, PharmD, BCOP Clinical Associate Professor, Pharmacy Practice University of Illinois at Chicago College of Pharmacy Oncology Resident Director, Ambulatory Pharmacy Services UI Health Chicago, IL Dr. Cuellar is a Clinical Associate Professor in the Department of Pharmacy Practice at the University of Illinois at Chicago (UIC) College of Pharmacy. Dr. Cuellar is a Board-Certified Oncology Pharmacist and works as a clinical oncology pharmacist at UI Health. She serves as the oncology residency program director, member of the DSMC, and vice-chair of the IRB. She is an invited lecturer, providing numerous national and international presentations on cardio-oncology, supportive care oncology, biosimilars, and oncology therapeutics. Faculty Kristi Orbaugh, MSN, RN, NP, AOCN Adult Nurse Practitioner Community Hospital Oncology Physicians Indianapolis, IN Kristi Orbaugh has spent her entire career in the oncology field. She received her undergraduate degree from Purdue University and her master’s degree from Indiana University—Purdue University of Indianapolis. She works as a nurse practitioner at Community Hospital Cancer Center North, which is an affiliate of MD Anderson. She has published several oncology-related articles. Ms. Orbaugh is passionate about oncology and enjoys presenting and providing oncology education on regional, national, and international levels. Disclosures Dr. Cuellar has disclosed that she has served as a consultant for Coherus Biosciences and Pfizer, Inc. Ms. Orbaugh has disclosed that she has served on the Speaker’s Bureau for Bristol-Myers Squibb, Coherus Biosciences, Dova, Immunomedics, Lilly, Morphos, Pfizer, Inc. and Rigel. The clinical reviewer, Megan May, PharmD, BCOP has no actual or potential conflict of interest in relation to this program. Susanne Batesko, BSN, RN, Robin Soboti, RPh, and Susan R. Grady, MSN, RN, as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business. Joint Accreditation Statement In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Postgraduate Healthcare Education. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Continuing Nursing Education The maximum number of hours awarded for this Continuing Nursing Education activity is 1.25 contact hours. Pharmacotherapy contact hours for Advanced Practice Registered Nurses will be designated on your certificate. Pharmacy Accreditation Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. UAN: 0430-9999-21-003-H01-P Credits: 1.25 hour (0.125 CEU) Type of Activity: Application Learning Objectives • Discuss the current data supporting short- and long-acting granulocyte-colony stimulating factor (G-CSF) use in prevention of febrile neutropenia and during the COVID-19 era • Formulate practical approaches to incorporating G-CSF biosimilars into healthcare system formularies and/or clinical pathways • Recognize the need for educational interventions that will improve healthcare providers’ understanding of G-CSF biosimilars use in cancer supportive care G-CSF Biosimilars Overview G-CSF Biosimilars Overview • Definition of a biosimilar • Brief overview of the approval process • Short- and long-acting G-CSF biosimilars currently available • Similarities and differences of currently approved biosimilars and originator products A Bio-What? Biosimilars • Biosimilar: a biologic product highly similar to a previously FDA-licensed biologic product that has been previously licensed by the FDA • Licensed product is referred to as the “reference product” • Derived from living organisms or living cells • Larger and much more complex than small molecule medications • Variability is allowed • No clinically meaningful difference in safety, potency, or purity Cook JW, et al. Ther Adv Med Oncol. 2019;11:1758835918818335. Biosimilar Approval Process • Demonstrate there are no clinically meaningful differences between reference product and biosimilar • Detailed analytical and structural testing • FDA reviews evidence from comparative analytical, nonclinical, clinical pharmacology, and clinical studies in a stepwise approach • Studies compare purity, potency, and efficacy to the reference product • Pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity studies • Human studies initially conducted in healthy subjects to reduce PK/PD variability Waller CF, Friganovic A. Future Oncol. 2020;16(25):1931-1939.;Lyman GH, et al. J Clin Oncol. 2018;36(12):1260-1265. Available G-CSF Biosimilars Short-acting FDA Approved Zarzxio (filgrastim-sndz) March 2015 Nivestym (filgrastim-aafi) July 2018 Pegylated, long-acting Fulphila (pegfilgrastim-jmdb) June 2018 Udenyca (pegfilgrastim-cbqv) November 2018 Ziextenzo (pegfilgrastim-bmez) November 2019 Nyvepria (pegfilgrastim-apgf) June 2020 European Medicines Agency has approved 8 filgrastim and 5 pegfilgrastim biosimilars Frazer MB, et al. J Oncol Pharm Pract. 2020;26(3 suppl):3-10. Similarities and Differences • Tbo-filgrastim (Granix) is not considered a biosimilar • Approved as an original biologic prior to development of FDA biosimilar process • Similar to the originator product, but a more limited indication • ASCO and NCCN guidelines • Some G-CSF biosimilars (i.e., filgrastim-aafi, filgrastim-sndz) have the same indications as the originator product • Other biosimilars have more limited indications • Filgrastim (Neupogen) has the only indication for acute radiation syndrome Wicherska-Pawlowska K, et al. J Clin Apher. 2020;35(1):4-8.; NCCN Clinical Practice Guidelines in Oncology. Hematopoietic Growth Factors. Version 2.2020– January 27,2020.; https://www.asco.org/practice-policy/policy-issues-statements/asco-in-action/media-issue-brief-biosimilars Discussion G-CSF Reference Products and Biosimilars in Supportive Care Supportive Care with Biosimilars • Febrile neutropenia prevention • Neutropenia treatment • Mobilization for hematopoietic stem cell transplantation • Neutrophil recovery post-hematopoietic stem cell transplantation • Coronavirus disease (COVID)-19 Neutropenia Prevention and Treatment • Neutropenia is a significant threat for patients with cancer • Affects approximately 50% of patients undergoing myelosuppressive chemotherapy • Febrile neutropenia prevention • NCCN recommends G-CSF for all patients receiving chemotherapy regimens deemed high risk (>20%) • Goal is to • Shorten length of neutropenia • Decrease hospitalization risk • Decrease length of hospitalization Smith TJ, et al. J Clin Oncol. 2015;33(28):3199-3212.; NCCN Clinical Practice Guidelines in Oncology. Hematopoietic Growth Factors. Version 2.2020– January 27,2020. Mobilization and Neutrophil Recovery • G-CSF originators and biosimilars can be used for: • Stem cell mobilization enhancement for HSCT • Neutrophil recovery post-HSCT • Post-treatment prophylaxis • Reduce number of days required for neutrophil engraftment post-treatment • Reduce antibiotic therapy and hospitalization length HSCT=hematopoietic stem cell transplantation Pahnke S, et al. Bone Marrow Transplant. 2019;54(6):858-866. Impact of COVID-19 Pandemic • NCCN extended recommendation for prophylactic G-CSF • Intermediate risk for FN (10% to 20%). • May also be appropriate in patients receiving low-risk regimens (<10%) • Multiple comorbidities or age puts them at higher FN risk https://www.nccn.org/covid-19/pdf/HGF_COVID-19.pdf Caution with COVID-19 • Consider discontinuing/avoiding G-CSF use in patients with • Respiratory symptoms • Respiratory infection • Confirmed or suspected COVID-19 • Decrease the risk of increased pulmonary inflammation • Decrease hypothetical risk of increased inflammatory cytokines • Associated with possible adverse outcomes https://www.nccn.org/covid-19/pdf/HGF_COVID-19.pdf Discussion Biosimilar Integration: Issues & Challenges Disrupting the Pharmaceutical Biologic Ecosystem Biologics are the cornerstone of cancer treatment Biologics are expensive and costs are increasing progressively Biosimilars increase market competition without compromising efficacy or safety University Hospitals Health System in Ohio •$>450,000 annualized cost avoidance implementation of biosimilar filgrastim-sndz Cost Kar I., et al. ASHP Midyear 2020 Poster Presentation. December 7, 2020. Savings: Real World Kalispell Regional Medical Center in Montana •Biosimilar peg-filgrastim-cbqv saved medical center $350,000 (12 months) Easley H, Klotz M. ASHP Midyear 2020 Poster Presentation.
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