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!

ASCO 2016: News in Head & Neck Cancer - Abstract 6008

Head and Neck Cancer

ASCO 2016. Abstract 6008. BERIL-1: A phase II, placebo-controlled study of buparlisib (BKM120) plus paclitaxel in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Denis Soulières et al.

Results: As of August 31, 2015, 158 pts were randomized to receive BUP + PAC vs PBO + PAC (n = 79 each), with 10 (13%) and 7 (9%) pts ongoing, respectively. Median age was 59 vs 58 years; 29% vs 39% of pts had laryngeal/hypopharyngeal primary tumors; 67% vs 79% were human papillomavirus (`)-negative; and 52% vs 38% had received a prior EGFR inhibitor. Primary reasons for treatment discontinuation were PD in 46% vs 60% of pts, and adverse events (AEs) in 9% vs 14%. Median PFS was improved for BUP vs PBO (4.6 vs 3.5 months; hazard ratio [HR] 0.65 [95% CI: 0.45–0.95]). Posterior probability of (HR < 1) was > 97.5%. The PFS improvement was consistent across exploratory subgroups. ORR was 39% vs 14%. Median OS at data cut-off was 10.0 vs 6.5 months (HR 0.71 [95% CI: 0.46–1.1]), based on 84/112 (75%) planned deaths. Grade 3/4 AEs ( ≥ 10% of pts) were hyperglycemia (22% vs 3%), anemia (18% vs 12%), neutropenia (17% vs 5%), and fatigue (8% vs 10%). 

Conclusions: The BERIL-1 study met its primary endpoint, demonstrating improved PFS for the combination of BUP + PAC vs PAC, notably in pts with poor prognosis HNSCC (73% of pts were HPV-negative). The safety profile of the combination was manageable. Follow-up for final OS analysis is ongoing. Clinical trial information:NCT01852292

CARE Faculty Perspective: The combination of buparlisib with paclitaxel is superior to taxanes. While a greater advantage was seen with HPV negative patients, some benefit was derived for HPV positive patients as well. We await the overall survival data.