- 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.
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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."
About BRENZYS™
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
www.merck.ca 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 (www.sec.gov).
References
___________________________
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:
https://www.cadth.ca/media/pdf/ES0284_SEBs_es_e.pdf
|
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.