On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada. Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic, and respiratory disease treatments. RYMTI is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial…
Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®). Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies. Company CEO Vinita Gupta commented, “FDA’s acceptance of our…
Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled…
Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical…
Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept). Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. According to the press releases, Lupin successfully completed its…
On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese pharmaceutical company. The clinical trial compared the safety and efficacy of YB113 to Amgen’s…