New Biosimilar can Offer an Effective and Lower Cost Treatment Option for Canadians Living with Rheumatoid Arthritis and Ankylosing Spondylitis

  • BRENZYS™ is the first subcutaneous anti-TNF biosimilar medicine approved in Canada
  • Biosimilars can provide a lower-cost option for patients starting on a new biologic treatment and could generate savings for the healthcare system
  • Transitioning patients from an originator biologic to a biosimilar beyond those starting on a new biologic treatment could generate additional savings for the healthcare system
  • Broader adoption of preferential listing for biosimilars as part of private drug programs can also create significant savings for most plan sponsors and plan members
  • BRENZYS™ represents the first approval for Samsung Bioepis in Canada as part of a biosimilars commercialization agreement with Merck

KIRKLAND, QC, Sept. 12, 2016 /CNW/ - Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that BRENZYS™ (etanercept) received approval in Canada for the treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis. BRENZYS™ is a biosimilar to the originator biologic Enbrel®* and the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar medicine available in Canada.

"The approval of BRENZYS™, biosimilar to etanercept, will allow cost savings for patients who require a biologic in the treatment of diseases such as rheumatoid arthritis and ankylosing spondylitis," said Dr. Janet Pope, Division Head in Rheumatology at St. Joseph's Health Centre, London. "The data demonstrated that BRENZYS™ had comparable efficacy and safety to the originator biologic Enbrel®. Given that 4 of the top 5 selling drugs in Canada are biologics  that can be used for the treatment of rheumatic diseases, the potential for biosimilars to reduce the cost of treating rheumatic diseases in Canada is significant."


*Enbrel® is the registered trademark of Amgen Canada Inc.


The Growth of Biologics in Canada
One of Canada's fastest-growing segments in pharmaceutical spending, biologics showed a growth rate for the 12 months ending May 2016 of 9.7%,1 compared to the total market growth rate of 6.3%.2

The Impact of Biosimilars on the Healthcare System

The cost of biologics affects provincial and private health plans.3 In the European Union and in Canada, biosimilars currently available are priced lower than their respective originator products,4 suggesting that their broader adoption would lead to cost savings.

The recent decision of the majority of Canadian provinces to provide preferential listing for an anti-TNF biosimilar for patients starting a new biologic treatment regimen is a good step towards greater savings. However, most private drug programs in Canada have yet to follow the lead of their public counterparts in giving preference to biosimilars. An opportunity exists for more group benefit providers and plan sponsors to mandate the greater use of biosimilars and benefit from cost savings while maintaining the overall quality of employee plans.  

"More private drug programs in Canada should embrace biosimilar use in preferential listings as their public counterparts have already done with an anti-TNF biosimilar," said Bruno Mäder, Head of the Merck Biosimilars Business Unit in Canada. "Moreover, as real-world evidence accumulates, strong consideration should also be given to the potential transitioning of treatment-experienced patients receiving the originator biologic to the biosimilar, in order to create additional savings for the system."


BRENZYS™ was approved in Canada on August 31, 2016 for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults. Treatment is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function. BRENZYS™ can be initiated in combination with methotrexate (MTX) in adult patients or used alone. BRENZYS is also indicated for reducing signs and symptoms of active ankylosing spondylitis.5 BRENZYS™ is not indicated for use in children less than 18 years of age. Therefore, it should not be used for children less than 18 years of age.6

The recommended dose of BRENZYS™ for adult patients with rheumatoid arthritis, or ankylosing spondylitis is 50 mg per week.7 BRENZYS™ is provided as a single-use, pre-filled syringe or a single-use, pre-filled, auto-injector (both are latex-free). The auto-injector is button-free and is designed for ease-of-use for patients.8

For more information about BRENZYS™, including details on the adverse drug reactions, please consult the product monograph.

Clinical Data Highlights

The approval of BRENZYS™ in Canada was supported by Samsung Bioepis' rigorous analytical, structural and functional testing, as well as a Phase I pharmacokinetics study and a Phase III clinical study comparing BRENZYS™ to the originator medicine, Enbrel®.

  • The phase III clinical study was a 52-week, double-blind, multicenter study that randomized 596 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.9 Analysis of the primary endpoint showed that BRENZYS had equivalent efficacy to Enbrel®, as shown by an ACR response at week 24 of 78.1% in the BRENZYS arm vs. 80.5% in the Enbrel® arm.10 The safety profile of BRENZYS™ was comparable to that of Enbrel® throughout the study.11
  • The adverse drug reaction profiles reported in the clinical trials that compared BRENZYS™ to Enbrel® did not show meaningful clinical differences. No new adverse reactions were reported.12 In the above mentioned phase III study, fewer injection site reactions for BRENZYS™ + methotrexate vs. Enbrel® + methotrexate were reported: Injection site reactions in 11 patients (3.7%) vs. 51 patients (17.2% for Enbrel® + MTX) (Most injection site reactions occurred early (between week 2 and week 8) and were mild in severity).13
  • At the EULAR 2016 congress, data was presented on the long-term safety and efficacy of BRENZYS™ in patients with rheumatoid arthritis in comparison between continuing BRENZYS™ and switching from Enbrel® reference biologic to BRENZYS™. Preliminary results on efficacy, safety and immunogenicity revealed no treatment-emergent safety or immunogenicity issues when transitioning patients from the originator product, Enbrel® to the biosimilar product, BRENZYS™.14

The approval of BRENZYS™ represents the first approval for Samsung Bioepis in Canada as part of its previously announced commercialization agreement with Merck & Co., Inc. to bring a diversified portfolio of high-quality biosimilar medicines to market over the coming years.

About Merck

For 125 years, Merck has been a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit and connect with us on YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2015 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (



1 IMS Brogan, PharmaFocus 2020, Canadian Drug Stores and Hospital Purchases, MAT May 2016.

2 ibid

3 Canadian Agency for Drugs and Technology in Health (CADTH), Environmental Scan, Issue 43, January 2014, Subsequent Entry Biologics – Emerging Trends in Regulatory and Health Technology Assessment Frameworks, p.19 Accessed August 16, 2016, available:

4 Ibid.

5 BRENZYS™ Product Monograph, Samsung Bioepis, 08.31.2016. Distributed by Merck Canada Inc, p.3-4

6 BRENZYS™, Op. Cit. p.4

7 BRENZYS™, Op. Cit. p.23

8 BRENZYS™, Op. Cit. p.24 and p.63

9 Emery P, Vencovsky J, Sylwestrzak A, et. al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2015, p2

10 Emery P, Op. Cit., p2

11 Emery P, Op. Cit., p4

12 Emery P, Op. Cit., p4

13 Emery P, Op. Cit., p4

14 Abdalla, A et al. Long term safety and efficacy of biosimilars infliximab among patients with inflammatory arthritis switched from reference product


SOURCE Merck Canada Inc.

Image with caption: "Merck announces approval of BRENZYS™ (etanercept) - the first subcutaneous anti-TNF biosimilar medicine approved in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. Biosimilars provide a lower-cost option for patients starting on a new biologic treatment and could generate savings for the healthcare system. (CNW Group/Merck Canada Inc.)". Image available at:

For further information: Media Contacts: Ani Armenian, Merck, 514-428-3395; Michael Kohn, Weber Shandwick, 416-642-7914; Karine Bergeron, Weber Shandwick, 514-668-7249

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890