Tagged as: Enbrel

Health Canada Approves Merck’s Etanercept Biosimilar for New Indications

On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications: Adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy; Pediatric patients ages 4 to 17…

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Lupin, Mylan Launch Etanercept Biosimilar in Germany

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…

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Sandoz Stipulates to Infringement of Certain Asserted Claims Prior to Etanercept Biosimilar Trial

As we have previously reported, the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar is scheduled to begin trial today before New Jersey District Judge Claire C. Cecchi. Yesterday, prior to the start of trial, the Court entered a stipulation wherein Sandoz stipulated to infringement of…

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DEAL WATCH: Lupin and Mylan Announce Partnership to Commercialize Etanercept Biosimilar

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…

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LG Chem Tests LBEC0101, a Biosimilar to Enbrel (etanercept), in Rheumatoid Arthritis

The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published.  The study evaluated the similarities between LBEC0101 and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid…

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