Biosimilar Development News
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Innovent Announces NMPA Granted New Indication Approvals For SULINNO® (Adalimumab Injection) For The Treatment Of Pediatric Plaque Psoriasis And Non-Infectious Uveitis
12/22/2020
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announces that SULINNO® (adalimumab injection), a recombinant human anti-TNF-α monoclonal antibody drug, has been officially approved by the National Medical Products Administration (NMPA) of China for two new indications, including the treatment of pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults who do not respond adequately to corticosteroids, require restraint of corticosteroids, or are not suitable for corticosteroid therapies.
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Biosimilar Interleukins Global Market Report 2020-30: COVID-19 Growth And Change
12/21/2020
83 billion in 2019 to $1.6 billion in 2020 at a compound annual growth rate (CAGR) of 93.0%. The slow growth despite being launched in 2019 is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges.
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AMCP Partnership Forum Develops Innovative Strategies To Support Biosimilar Use And Development
12/21/2020
Managed care experts representing payers, pharmacists, integrated delivery systems, health economists and analysts, patient advocates, academicians, pharmaceutical manufacturers, and other key decision-makers convened for AMCP's Partnership Forum, "Biosimilars: Policy, Practice, and Post-Marketing Surveillance to Support Treatment and Coverage Decisions," to identify actions that support biosimilar use and development.
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Bio-Thera Solutions Partners With Biomm To Market BAT1706 In Brazil
12/17/2020
Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached a licensing agreement with Biomm S.A. for BAT1706, its bevacizumab biosimilar, under which Biomm will have exclusive rights to distribute and market the drug in Brazil.
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Samsung Bioepis Releases ‘Education In Biosimilars’ Whitepaper, Exploring The Need For Better Education On The Innovation, Quality And Value Of Biosimilars
12/17/2020
Samsung Bioepis Co., Ltd. today launched a new whitepaper, entitled ‘Education in Biosimilars’, which has been developed following extensive research throughout 2020 to identify fundamental information gaps and unmet needs in the biosimilar space.
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NMPA Has Accepted The NDA Of HLX01 (Rituximab Injection) For The Treatment Of Rheumatoid Arthritis
12/17/2020
Shanghai Henlius Biotech, Inc. announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of its rituximab injection HLX01 to treat rheumatoid arthritis (RA).
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Sandoz Canada Receives Authorization From Health Canada To Launch New Biosimilar Hyrimoz® (adalimumab)
12/17/2020
Sandoz Canada Inc. announced today that Health Canada has authorized Hyrimoz® (adalimumab injection, reference biologic drug: Humira®) on November 4, 2020 for marketing in Canada.
- FDA Approves Amgen's RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan® (rituximab) 12/17/2020
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Samsung Bioepis Initiates Phase 3 Clinical Trial For SB16, Proposed Biosimilar To Prolia (Denosumab)
12/14/2020
Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB16, the company's proposed biosimilar referencing Prolia (denosumab). The Phase 3 clinical trial for SB16 (denosumab) is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB16 compared to Prolia in 432 women with postmenopausal osteoporosis.
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Celltrion Healthcare Receives EU CHMP Positive Opinion For Biosimilar Adalimumab, CT-P17
12/10/2020
Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of an adalimumab biosimilar candidate referencing Humira1, CT-P17 recommending approval for all available indications.