HERTFORDSHIRE, England and PITTSBURGH, and TOKYO – September 20, 2018 – Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for Hulio® (Product Code: FKB327), a biosimilar to AbbVie’s Humira® (adalimumab), for all indications.
The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Humira.
The EC approval of Hulio applies to all 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Mylan plans to launch Hulio across various markets in Europe after October 16. Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this year. Fujifilm Kyowa Kirin Biologics has a non-exclusive royalty bearing license with AbbVie (Mylan has a sublicense) for the use and sale of Hulio in European countries.
Mylan President Rajiv Malik commented, “We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio. This is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars, and we’re proud to be a leader in the market formation. We’ve made great progress with Fujifilm Kyowa Kirin Biologics and look forward to continuing this important collaboration.”
“We are delighted that Hulio has received approval from the European Commission” said Dr. Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics President and CEO. “The EC’s approval of Hulio marks a significant milestone. In cooperating with Mylan, we continue to commit all efforts to bring high quality and affordable biosimilars to patients throughout European countries.”
Mylan Europe President Jacek Glinka added, “Biosimilars represent a huge opportunity in Europe to drive better patient access through high quality, value medications that support healthcare systems across the region to deliver ongoing excellent care in the face of aging populations and increasingly stretched resources.”
Hulio is indicated for the same indications of Humira, including:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Hidradenitis suppurativa
- Crohn's disease
- Ulcerative colitis
- Polyarticular juvenile idiopathic arthritis (age 2 and older)
- Enthesitis-related arthritis (age 6 and older)
- Plaque psoriasis (age 4 and older)
- Crohn's disease (age 6 and older)
- Hidradenitis suppurativa (age 12 and older)
- Uveitis (age 2 and older)
Humira is the world's best-selling biologic medication. It had brand sales of approximately $4.4 billion in Europe for the 12 months ending June 30, 2018, according to IQVIA.
Adalimumab is an injectable, biologic medication which inhibits Tumour Necrosis Factor (TNF). This can cause inflammation in autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis. By specifically binding to TNF, adalimumab blocks its activity, thereby reducing inflammation and other disease symptoms.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
About Fujifilm Kyowa Kirin Biologics
Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President: Kenji Sukeno; hereinafter “Fujifilm”) and Kyowa Hakko Kirin Co., Ltd. (President and COO: Masashi Miyamoto, hereinafter “Kyowa Hakko Kirin”) on March 27, 2012 as a company for developing, manufacturing, and marketing biosimilars. Its pipeline includes an adalimumab biosimilar (Product Code: FKB327) and a biosimilar of the anti-VEGF humanized monoclonal antibody bevacizumab (Product Code: FKB238), a drug used to treat a range of cancers including colorectal and non-small cell lung cancer. Fujifilm Kyowa Kirin Biologics established Centus Biotherapeutics Ltd., a joint venture for the development and commercialization of FKB238 with AstraZeneca plc.
By merging the technologies in advanced production, quality control and analysis which Fujifilm has developed over many years through its photographic film business, with the proprietary technologies and know-how which Kyowa Hakko 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.
Forward-looking statements: Mylan
This press release includes statements that constitute "forward-looking statements", including with regard to Mylan planning to launch Hulio® across various markets in Europe next month. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: success of clinical trials and our or our partners' ability to execute on new product opportunities; any regulatory, legal or other impediments to our or our partners' ability to bring products to market; other risks inherent in product development; the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or our partners' businesses; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; the impact of competition; strategies by competitors or other third parties to delay or prevent product introductions; the effect of any changes in our or our partners' customer and supplier relationships and customer purchasing patterns; any other changes in third-party relationships; changes in the economic and financial conditions of the businesses of Mylan or its partners; uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.
Christine Waller (Media)
Fujifilm Kyowa Kirin Biologics
Kyowa Hakko Kirin Co., Ltd (for Fujifilm Kyowa Kirin Biologics)
Melissa Trombetta (Investors)
Fujifilm Corporation (for Fujifilm Kyowa Kirin Biologics)
DOP: September 2018