Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio® (adalimumab-fkjp)
"The FDA approval of Hulio marks a significant milestone for both Fujifilm Kyowa Kirin Biologics and Mylan, increasing access to affordable treatment for U.S. patients with inflammatory conditions." said Atsushi Matsumoto, Fujifilm Kyowa Kirin Biologics President and CEO. "In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world."
In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the
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.
Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for the commercialization of Hulio in
Humira had brand sales of approximately
Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. Hulio should be discontinued if a patient develops a serious infection or sepsis during treatment. Test for latent TB and if positive, begin TB treatment before initiating Hulio. Monitor all patients for active TB during treatment, even if the initial TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including Hulio. Post-marketing cases of hepatosplenic T-cell lymphoma have occurred in young adults with inflammatory bowel disease treated with TNF blockers including Hulio.
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 portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 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
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 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: Mylan
This press release includes statements that constitute "forward-looking statements," including with regard to bringing another treatment option to
Humira is a registered trademark of AbbVie.
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Mylan: Christine Waller (Media), 724.514.1968, Email: firstname.lastname@example.org; Melissa Trombetta (Investors), 724.514.1813, Email: InvestorRelations@mylan.com; Fujifilm Kyowa Kirin Biologics: Ryohei Kawai, Kyowa Kirin Co., Ltd (for Fujifilm Kyowa Kirin Biologics), +81-3-5205-7205, Email: email@example.com; Takuro Nishijima, FUJIFILM Holdings Corporation (for Fujifilm Kyowa Kirin Biologics), +81-3-6271-2000