Tagged as: denosumab

China Approves World’s First Denosumab Biosimilar

Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures.  Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive…

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Biosimilars Licensing Agreement Updates

Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market.  Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700…

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Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Denosumab Biosimilar

Alvotech announced this week the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to PROLIA® and XGEVA®, to demonstrate clinical similarity to PROLIA® in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis.  According to Alvotech, the results from this trial will be…

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Denosumab Clinical Trial Updates

The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars.  Here we report on the results of two recently completed studies. On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar denosumab candidate, ARYLIA, is noninferior to Amgen’s PROLIA for the…

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Organon and Henlius license agreement - Big Molecule Watch

Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA® (denosumab).  According to the press release, Henlius independently developed both biosimilar products.  Organon will acquire exclusive global commercialization rights except for China.  The agreement…

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Samsung Bioepis Initiates Phase 1 Trial of Ustekinumab Biosimilar

Earlier today, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB17, the company’s proposed biosimilar to Stelara® (ustekinumab).  The trial will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and Stelara®.  With the start of this trial, Samsung Bioepis has the following biosimilar candidates in…

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Biosimilar Market Update – Biocon Biologics LTD and Samsung Bioepis

Last week, Biocon Ltd announced the approval of approximately a 150 million USD capital injection from Goldman Sachs.  Dr. Christian Hamacher, CEO, Biocon Biologics, said, “This capital injection by Goldman Sachs will enable us to make prudent investments in R&D, high-quality manufacturing, as well as, establish a global commercial footprint.” …

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Denosumab biosimilar IND approval in China and teriparatide biosimilar launch in South Korea

Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved an investigation new drug (IND) application[1] of HLX14, a denosumab biosimilar.  Denosumab is a recombinant humanized anti-RANKL monoclonal antibody for injection that is approved for the treatment of postmenopausal women with osteoporosis with a high…

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