Mylan and Lupin Receive European Marketing Authorization for Nepexto®, Biosimilar Etanercept
The regulatory approval follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which was based on a biosimilarity assessment including preclinical and clinical studies demonstrating bioequivalence to Enbrel. In addition, a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity.
The centralized marketing authorization applies to all member countries of the
Enbrel had sales of approximately
Etanercept is an injectable, biologic medicine which inhibits Tumour Necrosis Factor (TNF). TNF is a key cytokine involved in the pro-inflammatory cascade in many chronic, immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis or plaque psoriasis. By specifically binding to TNF, etanercept 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 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 Lupin Limited
Lupin is an innovation-led transnational pharmaceutical company headquartered in
The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas. Lupin is the third largest pharmaceutical company in the
Lupin has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.
Forward-Looking Statements: Mylan
This press release includes statements that constitute "forward-looking statements," including with regard to the approval of Nepexto, a biosimilar etanercept, being a positive step forward as we work to broaden our biosimilars franchise offerings and do our part to increase access to biologic treatments for patients in many European countries; this milestone reflecting a strong scientific program behind Nepexto and commitment by our teams and our partner, Lupin, to bring the product to market as soon as possible; and looking forward to launching Nepexto in the second half of this year. 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 widespread and highly uncertain impact of public health outbreaks, epidemics and pandemics, such as the COVID-19 pandemic; any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in
Forward-Looking Statements: Lupin
This press release includes statements that constitute "forward-looking statements", including with regard to: Mylan and Lupin's commercialization of a biosimilar to Enbrel® (etanercept); that the introduction of biosimilars is an important mechanism to help increase access to more affordable biologics treatments, and Mylan's industry-leading portfolio of 20 biosimilar products positions Mylan to be at the forefront of delivering those savings; that Mylan looks forward to working closely with Lupin to bring their etanercept biosimilar to market and reach patients in
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MYLAN: Christine Waller (Media), 724.514.1968, Email: firstname.lastname@example.org or Melissa Trombetta (Investors), 724.514.1813, Email: InvestorRelations@mylan.com or LUPIN: Manjira Sharma (Media), GM - Corporate Communications, Email: email@example.com, Tel: +91 22 6640 2532 and Arvind Bothra (Investors), Head - Investor Relations and Corporate Communications, Email: firstname.lastname@example.org, Tel: +91 22 6640 8237