Lupin Introduces Rymti® Biosimilar Etanercept in Canada

Lupin Limited, a leading global pharmaceutical company based in Mumbai, India, has launched its first biosimilar in Canada named Rymti®. The drug is being introduced through Sandoz Canada, Lupin's partner. Rymti® is designed to treat various chronic inflammatory diseases including 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. This biosimilar has been approved for all therapeutic uses of its reference product, Enbrel®.

The approval of Lupin’s Etanercept, the active component in Rymti®, marks a significant milestone in the treatment of chronic inflammatory diseases. Initially approved by the PMDA in Japan in 2019, the EMA in Europe in 2020, and Health Canada in 2022, Etanercept has proven to be an effective therapy option for a range of severe autoimmune disorders. Its introduction to the Canadian market is expected to offer a cost-effective, efficient alternative to existing treatments.

Rymti® is available in a patient-friendly format, including a pre-filled pen and pre-filled syringe, which are easy to handle and latex-free. This design has shown high patient acceptance, potentially improving compliance among those needing regular injections. The convenience of the pre-filled pen is particularly appreciated, offering patients a more manageable self-injection option.

The biosimilar Rymti® mirrors the efficacy and safety profile of its reference product, Enbrel®, but at a more attractive price point. This cost-effectiveness could support sustainable healthcare by providing affordable treatment options without compromising quality. Rymti®'s approval by Health Canada in August 2022 signifies its readiness to meet the therapeutic needs of patients.

Vinita Gupta, the Chief Executive Officer of Lupin, expressed her satisfaction with the launch, underscoring the company's commitment to enhancing healthcare accessibility and affordability in Canada. Dr. Cyrus Karkaria, President of Biotechnology at Lupin, highlighted the global usage of Etanercept in managing severe autoimmune disorders and emphasized the company's dedication to expanding their portfolio to include effective and affordable biosimilars like Rymti®.

Michel Robidoux, President and General Manager of Sandoz Canada, commended the launch of Rymti® as a significant achievement for the company. The exclusive partnership with Lupin allows Sandoz Canada to introduce another Etanercept solution to the market, thereby increasing treatment options and accessibility for patients in Canada.

Etanercept is a biologic medication administered via injection that targets Tumor Necrosis Factor (TNF), a cytokine involved in the inflammatory processes of many chronic immune-mediated diseases. By binding to TNF, Etanercept inhibits its activity, reducing inflammation and alleviating disease symptoms. This mechanism of action makes Etanercept a valuable treatment for conditions such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis.

Lupin Limited is renowned for its innovation-led approach in the pharmaceutical sector. Headquartered in Mumbai, the company has a broad portfolio that includes both branded and generic formulations, biotechnology products, and APIs. Operating in over 100 markets globally, Lupin holds strong positions in cardiovascular, anti-diabetic, and respiratory segments, among others.

The company operates 15 manufacturing sites and seven research centers worldwide, employing over 20,000 professionals. Recognized consistently as a top employer in the Biotechnology & Pharmaceuticals sector, Lupin remains committed to research and development, investing 7.9% of its revenue in R&D during FY23.