Biosimilar Development News

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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).

37. 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.

38. FDA Approves Amgen's RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan® (rituximab) 12/17/2020
39. 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.

40. 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.