Press Release: CARE Congress on Biosimilars

On January 13th, 2017 CARE faculty specialists representing the fields of gastroenterology, hematology, oncology, respirology and rheumatology met to consider the integration of Biosimilars into the Canadian healthcare system.

Biosimilars are drugs that may replace expensive biologic drugs that are going off patent.  With biosimilars being relatively new to the Canadian landscape, there are also a number of questions/considerations on extrapolating data, interchangeability, immunogenicity, and systemic challenges (tracking and monitoring) that require attention.

Recognizing both the potential impact on the Canadian healthcare system and the importance of involving stakeholders, CARE faculty invited 16 speakers representing Canadian researchers, clinicians, Health Canada, public and private funding agencies, health economists, hospital pharmacists, nurses, advocacy groups, ethicists and legal experts to share perspectives, concerns, wants and needs.

An audience of 100+, representing the above named stakeholders, along with various levels of government, pharmaceutical companies and industry associations, listened in while speakers and assembled faculty discussed biosimilars from multiple perspectives.

The aim of this Congress is to increase collective understanding, consider education needs for specialists and assembled stakeholders, and ultimately refine a CARE guidance/position on Biosimilars.

 

CARE Faculty believes: 

  • Developing clinical practice through optimization of current therapies
  • Improving patient outcomes by developing innovative therapeutics
  • Ensuring access to quality care for all Canadians by the responsible and evidence-based use of treatment
  • Competition is welcomed to improve efficiency and access

 

CARE™ funding sources:

CARE™ receives unrestricted funding from multi-industry sponsors, institutions and associations. Content reflects the opinions, presentations and analyses of experts, investigators, educators and clinicians ("CARE Faculty"), whose activities, while independent, are commercially supported by the noted sponsor(s). Program content is developed independently of sponsor(s).

 

Background Steps that led up to this CARE™ Congress

  • CARE™ conducted needs assessments in oncology, hematology, rheumatology, and gastroenterology to understand current perceptions of biosimilars and their use in Canada
  • A multi-disciplinary group of CARE faculty members met October 27th, 2016 to discuss the various needs assessment data, and the impact biosimilars will have in Canada
  • There was consensus to host a larger meeting involving more stakeholders; CARE™ has worked to quickly assemble this Congress involving not only different specialties, but different stakeholder representatives.

For more information on the steering faculty, assembled CARE faculty, speaker list, or for questions/information needs regarding CARE, please contact Christina Lopes or Erica Duncan. 

 


References:

  1. Hirsch BR, Lyman GH. Biosimilars: are they ready for primetime in the United States? J Natl Compr Canc Netw. 2011;9: 934–943
  2. Based on 2013 sales of biologics with patents expiring before 2021 (Remicade, Eprex, Aranesp, Levemir, Humira, Avastin, Enbrel, Lucentis, Rituxan, Gonal-F). IMS Health Canada - Canadian Drug and Hospital (CDH) Sales, December 2013, page 11

Click here to view more highlights from the CARE Congress on Biosimilars.

Insights on the NOR-SWITCH trial are now available! Hear from Canadian experts Drs. Brian Feagan & John Marshall

Biologic therapy has revolutionized the treatment of IBD and improved patient outcomes drastically. Many of the biologic therapies we routinely use are now or soon going off patent and competitive molecules, subsequent entry biologics (SEBs), are now being introduced. SEBs have potential implications for our own practices but also for how we manage our pharmacy budgets and how we deliver health care in Canada.

The NOR-SWITCH trial was a randomized, open-label trial studying a cohort of patients who were stable or in remission on the innovator biologic, infliximab (REMICADE®). Patients were randomized to either continue with infliximab or switch to a SEB version of infliximab (INFLECTRA® in Canada). This was a cross specialty trial that included patients from a variety of diagnoses, including: rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, UC, CD and chronic plaque psoriasis. Each group was followed for different endpoints over the course of the trial.

CARE Gastroenterology Faculty lead, John Marshall (McMaster University), sat down with Dr. Brian Feagan (Professor of Medicine at the University of Western) to critically assess this study and discuss how the results should be interpreted and applied in Canadian practice.

 

Interested in learning more? Join us at The CARE Congress on Biosimilars!

EASL 2015. Late-breaking Oral 1. The Ruby-I Study

EASL 2015. Late-breaking Oral 1. The Ruby-I Study

P.J. Pockros(1), K R. Reddy(2), P.S. Mantry(3), E. Cohen(4), M. Bennett(5), M.S. Sulkowski(6), D. Bernstein(7), T. Podsadecki(4), D. Cohen(4), N.S. Shulman(4), D. Wang(4), A. Khatri(4), M. Abunimeh(4), E. Lawitz(8).

1. Scripps Clinic, La Jolla, 2. University of Pennsylvania, Philadelphia, 3. The Liver Institute at Methodist Dallas, Dallas, 4. AbbVie Inc., North Chicago, 5. Medical Associates Research Group, San Diego, 6. Johns Hopkins University, Baltimore, 7. North Shore University Hospital, Manhasset, 8. The Texas Liver Institute, University of Texas Health Science Center, San Antonio, United States

Conclusions: Among HCV GT1-infected patients with stage 4 or 5 CKD in this ongoing trial, the regimen of 3D±RBV has been well tolerated to date, with no treatment-related serious AEs, one hemoglobin decline to <8 g/dL, and no premature discontinuations of DAAs. All viral loads suppressed rapidly on treatment and there are no virologic failures to date. Available pharmacokinetic and SVR data will be presented.

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EASL 2015. Late-breaking Oral 8. Daclatasvir, Sofosbuvir, and Ribavirin Combination for HCV Patients with Advanced Cirrhosis or Post-Transplant Recurrence: Phase 3 ALLY-1 Study

EASL 2015. Late-breaking Oral 8. Daclatasvir, Sofosbuvir, and Ribavirin Combination for HCV Patients with Advanced Cirrhosis or Post-Transplant Recurrence: Phase 3 ALLY-1 Study

ALLY-1 is a multicentre, open label, phase 3 study examines the efficacy of Daclatasvir (DCV), sofosbuvir (SOF) and ribavirin (RBV) in HCV infected patients who either had advanced cirrhosis, or those who were post-liver transplant. Although all genotypes could be enrolled in the study, the primary endpoint was SVR12 in genotype 1 patients. Both treatment naïve (TN) and treatment experienced (TE) patients were enrolled, and DAA failures were allowed, except for patients who had had previous exposure to NS5A inhibitors.

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EASL 2015. Late-breaking Poster 12. Silymarin for the Treatment of Non-Alcoholic Steatohepatitis: Interim Analysis of a Randomized, Double-blind, Placebo-controlled Trial

EASL 2015. Late-breaking Poster 12. Silymarin for the Treatment of Non-Alcoholic Steatohepatitis: Interim Analysis of a Randomized, Double-blind, Placebo-controlled Trial

This is a randomized, double-blind, placebo-controlled trial examining the efficacy of silymarin (milk thistle) at a dose of 700mg PO TID in the Malaysian population, the interim results of which were presented after 48 weeks of treatment NASH was diagnosed with a baseline liver biopsy, a repeat of which was performed at the end of the study. A total of 30 patients were in the treatment arm, compared to 34 patients in the placebo group. The primary endpoint was defined as at least a 30% improvement in the NAFLD Activity Score (NAS), whereas histological endpoint was defined as an improvement in fibrosis stage, regardless of the change in NAS.

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EASL 2015. Late-breaking Poster 17. Novel Approach for the Prevention of Recurrent Hepatitis C in Liver Transplant Recipients: Preliminary Results from Ongoing Phase III Trial with Civacir®

Using a system dynamic model, we quantified the HCV-infected population in Canada (2014-2035). 36 age/gender-defined cohorts were tracked to define HCV prevalence, complications and mortality. Baseline assumptions, transition probabilities and SVR rates were extracted from the literature, and the availability of novel treatments (Rx) was based on expert opinion (2016: all-oral Rx for G1-3; 2018: pan-genotypic all-oral Rx).

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CASL 2015. Abstract A22. Feasibility of Hepatitis C Virus Disease Elimination in Canada Within Two Decades

CASL 2015. Abstract A22. Feasibility of Hepatitis C Virus Disease Elimination in Canada Within Two Decades

This study is incredibly important Canadian work.  Treating HCV in small numbers will not impact the overall public health burden of the disease according to several analyses, but how much HCV we should be treating in Canada is unknown.  This paper provides practical policy approaches to possibly eliminate HCV from Canada, with the best approach being one that treats patients with more advanced fibrosis today, then expanding to patients with less advanced disease.  Coupled with creative methods to amortize the costs of HCV meds, this strategy really could work.  Of course, HCV will never be eliminated with treatment alone, but a sizeable advance could be made in reducing the complications of this curable infection with a ‘progressive strategy’.

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