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Amgen and Pfizer Developing More Interchangeable Biosimilars

In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars.  Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab).  Pfizer also…

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Bevacizumab Biosimilar Demonstrates Positive Phase 3 Results for the Treatment of Non-Small Cell Lung Cancer

A study recently published in Cancer Communications reported that LY01008 or BOYOUNUO, a bevacizumab biosimilar developed by Shandong Boan Biotechnology Co., Ltd. (“Shandong Boan”), a subsidiary of Luye Pharma Group Ltd. (“Luye Pharma”), demonstrated comparable safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product AVASTIN in patients with advanced…

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Amgen Canada Launches Adalimumab Biosimilar

On May 4, 2021, Amgen Canada announced the launch of their adalimumab biosimilar AMGEVITA (reference drug HUMIRA) for the treatment of 11 chronic inflammatory conditions.  AMGEVITA is available as a prefilled syringe and a prefilled pen (SureClick® autoinjector) with a range of pack sizes to support dosing according to the…

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Huon Announces Prolia Biosimilar

On April 20, 2021, Korean company Huon Labs announced that it will develop a PROLIA biosimilar using PanGen Biotech’s cell culture and purification technology.  PROLIA (denosumab), an Amgen product, is indicated to reduce the risk of facture in patients with osteoporosis with a particular concentration on patients that are postmenopausal…

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Adalimumab Biosimilars Ready To Enter Australian, Korean, Japanese and European Markets

On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co.  HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and…

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