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Genentech appeals district court’s refusal to block Amgen’s trastuzumab and bevacizumab biosimilars

As we previously reported, Amgen commercially launched two biosimilars in the United States earlier this month: KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin®; and MVASI® (bevacizumab-awwb), a biosimilar to Avastin®.  Amgen’s launch announcement on July 18, 2019 came shortly after a Delaware federal district court denied Genentech’s requests for a temporary…

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Mylan and Upjohn to Join Forces

Mylan N.V. and Pfizer Inc. recently announced that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine to form a new company.  According to the press release, each Mylan share would be converted into one share of the new company.  Pfizer shareholders will own 57% of the combined new company,…

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FDA Approves RUXIENCE, Pfizer’s Rituximab Biosimilar Product

On July 23, 2019, the FDA approved Pfizer’s aBLA for RUXIENCE (rituximab-pvvr), a biosimilar of Genentech’s RITUXAN.  According to its approved package insert, RUXIENCE is indicated for the treatment of certain types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis. RUXIENCE is the twenty-second…

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BREAKING NEWS: Federal Circuit Affirms Coherus Victory Over Amgen in Pegfilgrastim Patent Dispute

As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for…

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FDA Approves Samsung Bioepis's HADLIMA (adalimumab-bwwd)

Earlier this week, the U.S. FDA approved Samsung Bioepis’s  HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…

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Regulatory Update - 7/22/2019

Sandoz announced today that it has enrolled the first patient in the ROSALIA Integrated Phase I/III study for its proposed biosimilar denosumab to confirm matching efficacy, safety and immunogenicity with the reference medicine, Amgen’s PROLIA in patients with postmenopausal osteoporosis.  The trial aims to study approximately 520 menopausal patients with osteoporosis…

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