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.

ACR 2016 News in Rheumatology: Psoriatic Arthritis

ACR 2016. Abstract 1657. Soluble Biomarkers May Differentiate Psoriatic Arthritis from Osteoarthritis

Vinod Chandran et al.

Results: Univariate analyses revealed the following markers significantly differed across groups (p<0.001): COMP, hyaluronan; resistin, HGF, insulin, leptin; CRP, IL -6, -8, TNF-α, MCP-1, NGF. When comparing PsA to OA controlling for age and sex, the following markers significantly differed (p<0.001): COMP ; resistin, HGF, insulin; IL-6, -8, TNF-α, MCP-1, NGF; and Adipsin (p<0.03). Multivariate analysis demonstrated that COMP (OR 1.24, 95% CI 1.06, 1.46), resistin (OR 1.26, 95% CI 1.07, 1.48), MCP-1 (OR 1.28, 95% CI 1.01, 1.48) and NGF (OR <0.001, 95% CI <0.001, 0.25) were independently associated with PsA vs. OA. The area under the ROC curve (AUROC) for this model was 0.99. Internal cross-validation of the model consistently identified MCP-1 as a PsA marker. Further validation of the model including COMP, resistin, MCP-1 and NGF in an independent sample set showed an AUROC of 0.98 (Figure).  

Conclusion: A panel of 4 biomarkers (COMP, resistin, MCP-1, NGF) may distinguish PsA from OA. Clinical utility of these markers will need to be determined in prospective studies.              

CARE Faculty Perspective: One of the challenges in diagnosing psoriatic arthritis is differentiating it from osteoarthritis, especially erosive hand osteoarthritis. This early proof-of-concept study indicates that a panel of soluble biomarkers may be useful in making the diagnosis. These markers will now need to be further verified and validated as well as clinical utility and cost-effectiveness determined.