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Biosimiliar Toolkit

Centene Corporation is a diversified, multi-national healthcare enterprise providing a comprehensive portfolio of innovative services including healthcare coverage for Medicaid, Medicare and the Health Insurance Marketplace. Centene also contracts with other healthcare and commercial organizations to provide specialty services for improved healthcare outcomes. We align the foundation of our purpose, transforming the health of the community, through enhancing patient health outcomes and lowering healthcare costs.

We have identified an opportunity to maintain quality of care for your patients while reducing overall healthcare costs through therapeutically interchanging patient treatment from reference biological medications to clinically appropriate biosimilar alternatives. Included in this packet are valuable resources that outline additional information on biosimilars for you and your patients.

The emergence of biological medications has transformed healthcare through targeted efficacy for numerous complex health conditions. As healthcare expenditures rise, biosimilar agents represent an opportunity to reduce healthcare costs while maintaining patient access to vital therapies. We request providers prescribe biosimilar agents to align with the foundation of our purpose.

  • Biosimilar drugs are FDA-approved, safe and effective medicines that are highly similar to existing biologic medicines.
  • The FDA regulates biosimilar manufacturing to ensure the biosimilar drugs are safe and effective, showing no clinically meaningful differences from the originator products.
  • Biosimilars are dosed and taken the same way as their biologic reference product. 

Source: US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity

  Increased Access for Patients

  • Introduction and development of biosimilars provides additional treatment options for patients and doctors at a lower cost.
  • These savings may facilitate increased access to new biologics and biosimilars, resulting in superior health outcomes.
  • Competition may increase in the healthcare market.

Source: Patient Materials: Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer

  Reduction in Healthcare Costs

  • As biosimilar availability increases, healthcare providers may be able to acquire biosimilars at a reduced wholesale cost.
  • Increased availability may reduce out-of-pocket costs for patients with co-insurance and copayments.

The Food and Drug Administration (FDA) defines a biosimilar agent as a “biological product that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.” FDA’s statement continues, that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” There are currently 26 FDA approved biosimilar drugs with more anticipated in the future. The Biologics Price Competition and Innovation Act (BPCI Act), created an abbreviated approval process for a biological product that is demonstrated to be biosimilar to a reference product. The FDA approves a product as biosimilar by utilizing data derived from analytical, animal, and clinical studies.

According to the FDA, biosimilars can be used in patients who have previously been treated with the reference product (treatmentexperienced), as well as in patients who have not previously received the reference product (treatment-naïve). Leading academic medical associations advocate for the use of biosimilar agents. In 2018 the American College of Rheumatology recommended biosimilar use, encouraging providers to incorporate these drugs into the treatment plans of patients with rheumatologic diseases where appropriate. The American Society of Clinical Oncology (ASCO) published a statement, also in 2018 on biosimilar agents, supporting their use where clinical trials demonstrated sufficient evidence.

Biosimilar agents are safe. The European Medicines Agency (EMA) first approved biosimilar drugs in 2006. After more than 10 years of post-marketing surveillance, there have been no reported differences in the safety profile of biosimilar agents compared with their originators. As healthcare expenditures rise, biosimilars represent a clear strategy to help control cost while maintaining quality. Medical professionals and patients need familiarity with biosimilars to assure confidence in their therapeutic equivalence.

The European Union pioneered the regulation of biosimilars since the approval of somatropin in 2006. Globally, there is extensive pharmacovigilance and experience proving safety and efficacy of these agents. Since 2006, there are more than 55 biosimilar agents approved in Europe and 26 biosimilar agents approved in the US.

What is a biosimilar?

Described by the US Food and Drug Administration (FDA), a biosimilar is “biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components.” “There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”

Are biosimilars considered generic medications?

A biosimilar is not considered as a generic of a biological medicine. This is due to natural variability and complex manufacturing of biological medicines, which do not allow an exact replication.

How are biosimilar approved in the US?

The Biologics Price Competition and Innovation Act (BPCI Act), created an abbreviated approval process for a biological product that is demonstrated to be biosimilar to a reference product. Through this application process, the biosimilar product can rely on certain existing scientific knowledge about the safety,purity, and potency of the reference product to support licensure.1

How can we get more information?

Please go to www.centene.com

Sources: 

Physicians may have concerns regarding switching patients on stable, long-term therapy from a reference biologic to a biosimilar. The possibility of increased immunogenicity following switching from a reference product to a biosimilar is a concern for many physicians and patients. The table below includes trials supporting the switch between biosimilar and reference product. It is important to note that while multiple switches between biosimilars and their reference products are not expected, the increasing number of biosimilars entering the market could trigger these scenarios.

Trials supporting the switch between biosimilar and reference product
REFERENCE PRODUCT BIOSIMILAR TRIALS SUPPORTING THE SWITCH

REMICADE

(INFLIXIMAB)

Inflectra

(infliximab-dyyb)

Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: Open-label extension of the NOR-SWITCH trial
  • A 26 week extension study (NOR-X) was performed to assess the efficacy, safety, and immunogenicity in patients maintained with Inflectra versus patients switching from Remicade to Inflectra
  • This study included 380 patients who had Crohn’s Disease (127; 33%), Ulcerative Colitis (80, 21%), Spondyloarthritis (67,18%), Rheumatoid Arthritis (55, 15%), Psoriatic Arthritis (20, 5%), and Chronic Plaque Psoriasis (31, 8%)
  • Study results showed no difference in safety and efficacy in patients maintained on Inflectra and those switched from Remicade to Inflectra

Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease
  • In a prospective observational cohort study, all adult IBD patients (195 Crohn’s Disease, 118 Ulcerative Colitis) on Remicade treatment, at four hospitals, were switched to Inflectra
  • Study results showed no significant changes in clinical disease activity, drug trough levels, patient QOL, or proportion of patients in remission

Renflexis

(infliximab-abda)

Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomized, double-blind, phase III transition study.
  • This study followed 584 patients that: a) started on Renflexis and continued on Renflexis, b) started on Remicade and continued on Remicade, and c) started on Remicade and switched to Renflexis at week 54
  • Study results showed that efficacy, safety and immunogenicity profiles remained comparable in all treatment groups up to week 78

EPOGEN/PROCRIT

(EPOETIN ALFA)

Retacrit

(epoetin alfa-epbx)

Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis
  • 434 patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen® were randomized 1: 1 to switch to IV Retacrit or continue standard-of-care (Epogen®) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm
  • The study concluded switching to Retacrit was non-inferior to continuing -Epogen in maintaining hemoglobin levels in patients receiving hemodialysis, when both ESAs were dosed using a specified algorithm

NEULASTA

(PEGFILGRASTIM)

Udenyca

(pegfilgrastim-cbqv)

No Studies Available*

Fulphila

(pegfilgrastim-jmdb)

Safe Switch of Treatment From the Reference Product to RGB-02, a Proposed Biosimilar Pegfilgrastim: Analysis of the Results of Three Clinical Trials
  • Efficacy, safety and PD data of two PK/PD studies (enrolling 110 and 150 healthy volunteers, respectively) and a comparative efficacy and safety study (enrolling 239 breast cancer patients) were analyzed in order to assess whether treatment switch from Neulasta® to RGB-02 has any impact on the PD response, efficacy or safety.
  • Patients in the reference arm of the comparative efficacy and safety study were switched to RGB-02 treatment following the first two chemotherapy cycles.
  • The mean duration of severe neutropenia (DSN) values after the therapy switch were similar to the values prior to the switch and the switched arm did not show decreased efficacy compared to the arm received RGB-02 from the first cycle. Safety results, including immunogenicity of the studies did not reveal any negative impact of the treatment switch.

NEUPOGEN

(FILGRASTIM)

Zarxio

(filgrastim-sndz)

randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.
  • This study evaluated 109 patients who completed the study after randomization to receive only one product (biosimilar or reference) and two arms received alternating treatments every other cycle (biosimilar then reference or vice versa over six cycles).
  • The study found non-inferiority after switching between reference product and biosimilar and there were no clinically meaningful results after switching regarding efficacy, safety or immunogenicity.

Nivestym

(filgrastim-aafi)

No Studies Available*

AVASTIN

(BEVACIZUMAB)

Mvasi

(bevacizumab-awwb)

No Studies Available*

Zirabev

(bevacizumab-bvzr)

No Studies Available*

HERCEPTIN

(TRASTUZUMAB)

Ogrivi

(trastuzumab-dkst)

No Studies Available*

Sources:

  • Goll GL, Jørgensen KK, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.
    J Intern Med. 2019;285(6):653–669. doi:10.1111/joim.12880
  • Bergqvist V, Kadivar M, Molin D, et al. Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease.
    Therap Adv Gastroenterol. 2018;11:1756284818801244. Published 2018 Oct 11. doi:10.1177/1756284818801244
  • Smolen JS, Choe JY, Prodanovic N, et al. Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study.
    Ann Rheum Dis. 2018;77(2):234–240. doi:10.1136/annrheumdis-2017-211741
  • Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis.
    Am J Nephrol. 2018;48(3):214–224. doi:10.1159/000492621
  • Illes A, Perjesi L, Horvat-Karajz K, et al. Safe switch of treatment from the reference product to RGB-02, a proposed biosimilar pegfilgrastim: Analysis of the results of three clinical trials.
    Ann Oncol. 2018;29 Suppl 8:viii608–viii609. doi:10.1093/annonc/mdy300.017
  • Blackwell K, Gascon P, Krendyukov A, Gattu S, Li Y, Harbeck N. Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.
    Ann Oncol. 2018;29(1):244–249. doi:10.1093/annonc/mdx638
  • Switching from Avastin or other Bevacizumab Biosimilars to Biosimilar Mvasi: Clinical Effectiveness.
    Ottawa: CADTH; 2018 Nov. (CADTH rapid response report: reference list)