Lupin : May 3, 2024 Lupin Launches Rymti® Biosimilar Etanercept in Canada

• Rymti® is Lupin's first biosimilar launch in Canada
• Rymti® is approved for all indications of the reference product Enbrel®
• Rymti® is available as an injectable in an easy-to-use pre-filled pen and a pre-filled syringe
• The approval of Rymti® by Health Canada underlines the scientific success of Lupin's biosimilar programs

Mumbai, India | Boucherville, Canada, May03, 2024: Global pharma major Lupin Limited (Lupin) today announced the launch of Rymti®, Lupin's first biosimilar in Canada, through its partner Sandoz Canada (Sandoz). Rymti® is indicated for the treatment of moderate to severe active rheumatoid arthritis, juvenile idiopathic arthritis, active and progressive psoriatic arthritis, severe axial spondyloarthritis, moderate to severe plaque psoriasis and chronic severe plaque psoriasis in children and adolescents. Rymti® is approved for all therapeutic indications of the reference product Enbrel®.

Etanercept as an established therapy option
Lupin's Etanercept was first approved for the treatment of rheumatoid arthritis by PMDA in 2019, EMA in 2020, Health Canada in 2022, and since then has offered an effective treatment option for several chronic inflammatory diseases.

Patient friendly application by means of pre-filled pen
Rymti® is available as a solution for injection in a pre-filled pen and pre-filled syringe. Data show a high patient acceptance of the easy-to-handle pre-filled pen. Patients favored this latex-free device for self-injection, which can lead to improvement in compliance.

Cost-effective treatment with Rymti®
Rymti®, with an equivalent efficacy and safety to reference product Enbrel®, is an attractive cost-effective treatment alternative that can contribute to sustainable healthcare and treatment options. The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada's drug regulator, Health Canada (HC), in August 2022, for all indications of the reference product Enbrel.

"We are delighted to announce the launch of Rymti®, Lupin's first biosimilar in Canada through our partner Sandoz," said Vinita Gupta, Chief Executive Officer, Lupin. "With this important milestone, we continue to advance healthcare accessibility and affordability for patients in Canada."

"Etanercept is used globally in the fight against a range of severe autoimmune disorders. We are happy to bring etanercept to the patients in Canada. We have diligently worked to build our portfolio to include etanercept ensuring patients have access to effective and affordable equivalent. This launch demonstrates our commitment to fostering healthcare solutions that truly make a difference," said Dr. Cyrus Karkaria, President Biotechnology, Lupin.

Michel Robidoux, President and General Manager, Sandoz Canada said, "The launch of Rymti® is a key milestone for Sandoz Canada. Thanks to our exclusive partnership with Lupin, we're adding another etanercept option on the Canadian market, increasing access for patients."

About Etanercept
Etanercept is an injectable biologic medicine that inhibits the biological activity of Tumor 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 and plaque psoriasis. Etanercept as a soluble TNF receptor fusion protein specifically binds to TNF and blocks its activity, thereby reducing inflammation and disease symptoms.

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
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For further information or queries please contact -
Heena Dhedhi
Deputy General Manager - Corporate Communications
Email: heenadhedhi@lupin.com

*Safe Harbor Statement

Enbrel® is a registered trademark of Amgen in US & Canada and Pfizer in rest of the world.
Rymti® is a registered trademark of Lupin Healthcare (UK) Limited