TORONTO and PITTSBURGH,
Feb. 18, 2021 /CNW/ -- Viatris
Inc. announced today that Health Canada has approved
Hulio®i, and product is now available in Canada. Hulio® is a biosimilar
to AbbVie's Humira®ii (adalimumab). It is licensed
from Fujifilm Kyowa Kirin Biologics Co., Ltd. and approved for all
adalimumab indications.
Viatris Canadaiii General Manager David Simpson commented, "We are very pleased
with Health Canada's approval of Hulio®, a biosimilar to
the world's top-selling drug Humira®. This milestone
brings another treatment option to Canadian patients living with
chronic inflammatory conditions and demonstrates our unwavering
belief that better access leads to better health. This is a
significant development for patients. We look forward to our
continued work with the provinces and private insurers to support
the successful implementation of Hulio®
reimbursement."
"Biosimilars such as Hulio®, are a key element to
sustain affordable healthcare as they offer a significantly lower
cost compared to the original biologic medicines. The benefits in
cost savings to healthcare systems can be significant," said Dr.
Michelle Teo, MD, FRCPC.
Viatris President of Developed Markets Tony Mauro shared, "Today's launch of
Hulio®, in partnership with Fujifilm Kyowa Kirin
Biologics, is yet another testament to the power of Viatris' unique
Global Healthcare Gateway®. With Viatris, partners like
Fujifilm Kyowa Kirin Biologics can further expand patient access to
more affordable biosimilar medicines in more markets around the
world, including here in Canada.
By leveraging our unmatched global infrastructure and regulatory
expertise, Viatris strives to be a Partner of Choice™ for companies
seeking to empower more people worldwide to live healthier at every
stage of life. With one of the industry's largest and most diverse
global biosimilars franchises, we are committed to improving
patient access to Hulio® and other critically important
biologic medicines as well as providing more affordable treatment
options for the patients we serve."
The approval of Hulio® was based on a
comprehensive analytical, preclinical and clinical program. The
Phase 3 clinical study, ARABESC, conducted by Fujifilm Kyowa Kirin
Biologics, demonstrated no clinically meaningful differences in
terms of safety, efficacy and immunogenicity compared with the
reference product, Humira®, in rheumatoid arthritis
patients.
Hulio® is indicated for the same indications as
Humira®, including:
Adults
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque Psoriasis
- Hidradenitis suppurativa
- Crohn's disease
- Ulcerative colitis
- Uveitis
Children
- Polyarticular juvenile idiopathic arthritis (age 2 and
older)
- Crohn's disease (13 to 17 years of age weighing ≥ 40 kg)
- Hidradenitis suppurativa (12 to 17 years of age weighing ≥ 30
kg)
- Uveitis (age 2 and older)
Humira® is the world's top-selling biologic
medication. It had brand sales of approximately $955
million in Canada for the 12 months
ending October 31, 2020, according to IQVIA.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new
kind of healthcare company, empowering people worldwide to live
healthier at every stage of life. We provide access to medicines,
advance sustainable operations, develop innovative solutions and
leverage our collective expertise to connect more people to more
products and services through our one-of-a-kind Global Healthcare
Gateway®. Formed in November
2020 through the combination of Mylan and Pfizer's Upjohn
business, Viatris brings together scientific, manufacturing and
distribution expertise with proven regulatory, medical and
commercial capabilities to deliver high-quality medicines to
patients in more than 165 countries and territories. Viatris'
portfolio comprises more than 1,400 approved molecules across a
wide range of therapeutic areas, spanning both non-communicable and
infectious diseases, including globally recognized brands, complex
generic and branded medicines, a growing portfolio of biosimilars
and a variety of over-the-counter consumer products. With a global
workforce of approximately 45,000, Viatris is headquartered in the
U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at
viatris.com and investor.viatris.com, and connect with us on
Twitter at @ViatrisInc, LinkedIn and YouTube.
About Fujifilm Kyowa Kirin Biologics
Fujifilm Kyowa
Kirin Biologics was established by FUJIFILM Corporation
(President: Kenji Sukeno; hereinafter "Fujifilm") and Kyowa
Kirin Co., Ltd. (President and COO: Masashi Miyamoto,
hereinafter "Kyowa Kirin") on March 27, 2012 as a company
for developing, manufacturing, and marketing biosimilars.
By merging the advanced technologies in production, quality
control and analysis which Fujifilm has developed in its relentless
pursuit of innovation, with the proprietary technologies and
know-how which Kyowa Kirin has accumulated through its
biopharmaceutical R&D and manufacturing, Fujifilm Kyowa Kirin
Biologics creates revolutionary production processes and reduces
costs for the production of biosimilars. Through this partnership,
the company will develop and manufacture reliable, high quality,
cost-competitive biosimilar products and commercialize these
products in a timely manner. With this strategy, Fujifilm Kyowa
Kirin Biologics aims to hold a leading position in the expanding
biosimilar market.
You can learn more about the business at:
fujifilmkyowakirin-biologics.com
Forward-looking statements
This press release includes
statements that constitute "forward-looking statements." These
statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such forward
looking statements may include statements about the
approval and launch of Hulio® in Canada, that today's launch of
Hulio®, in partnership with Fujifilm Kyowa Kirin
Biologics, is yet another testament to the power of Viatris' unique
Global Healthcare Gateway®, and that by leveraging our
unmatched global infrastructure and regulatory expertise,
Viatris strives to be a Partner of Choice™ for companies seeking to
empower more people worldwide to live healthier at every stage of
life. Because forward-looking statements inherently involve
risks and uncertainties, actual future results may differ
materially from those expressed or implied by such statements.
Factors that could cause or contribute to such differences include,
but are not limited to: the potential impact of public health
outbreaks, epidemics and pandemics, including the ongoing
challenges and uncertainties posed by the COVID-19 pandemic; the
integration of Mylan N.V. and Pfizer Inc.'s Upjohn business (the
"Upjohn Business"), which combined to form Viatris (the
"Combination") and the implementation of our global restructuring
initiatives being more difficult, time consuming or costly than
expected, or being unsuccessful; the ability to achieve
expected benefits, synergies and operating efficiencies in
connection with the Combination or its restructuring initiatives
within the expected timeframe or at all; actions and decisions of
healthcare and pharmaceutical regulators; changes in healthcare and
pharmaceutical laws and regulations in the U.S. and abroad; any
regulatory, legal or other impediments to Viatris' ability to
bring new products to market; Viatris' or its
partners' ability to develop, manufacture and commercialize
products; the scope, timing and outcome of any ongoing legal
proceedings and the impact of any such proceedings; any significant
breach of data security or data privacy or disruptions to our
information technology systems; risks associated with international
operations, including our operations in China; the ability to
protect intellectual property and preserve intellectual property
rights; changes in third-party relationships; the effect of any
changes in Viatris' or its partners' customer and supplier
relationships and customer purchasing patterns; the impacts of
competition; changes in the economic and financial conditions of
Viatris or its partners; uncertainties and matters beyond the
control of management; and the other risks Viatris' filings with
the Securities and Exchange Commission. Viatris routinely uses its
website as a means of disclosing material information to the public
in a broad, non-exclusionary manner for purposes of the SEC's
Regulation Fair Disclosure (Reg FD). Viatris undertakes no
obligation to update these statements for revisions or changes
after the date of this release other than as required by
law.
i Hulio® is a registered trademark of Fujifilm
Kyowa Kirin Biologics; licensed use by BGP Pharma ULC, a Viatris
company.
ii Humira® is a product of AbbVie Corporation.
iii Viatris Canada is the business name for the
businesses carried on by each of Mylan Pharmaceuticals, BGP Pharma
ULC and Upjohn Canada ULC.
SOURCE Viatris Inc.