Viatris Launches Hulio® (adalimumab biosimilar) in Canada

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.

Kerri Elkas (Media), +1.416.236.2631, [e-mail], [e-mail], http://www.viatris.com