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EMA publishes details of Celltrion’s Yuflyma® (biosimilar adalimumab)
The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injections’.
Cipla expands biosimilar partnership with Alvotech for ANZ
Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).
Coherus reports Q420 and Full Year 2020 financial results
Coherus released its Q420 and Full Year 2020 financial results. Coherus reported it has captured 21% of the pegfilgrastim market and nearly 50% of the pre-filled syringe segment in the US. Additionally, Coherus announced it plans to file its BLA for its ranibizumab biosimilar mid-year 2021. Coherus also confirmed that it plans to launch its adalimumab biosimilar in the US on or after July 1, 2023.
Fresenius Kabi announces it will launch its biosimilar adalimumab in Australia in Q2 2021
In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021. Additionally, Fresenius Kabi announced it will launch its biosimilar pegfilgrastim in the US and the EU in Q3/4 2021. Fresenius Kabi’s biosimilar tocilizumab candidate is planned for launch in the US and the EU in 2023. An undisclosed autoimmune biosimilar is planned for a 2024 launch, and an oncology biosimilar in 2025.
Viatris launches Hulio® (biosimilar adalimumab) in Canada
Viatris announced it has launched Hulio® (biosimilar adalimumab) in Canada. Hulio® is available in a 50mg/ml formulation (40mg/0.8mL) and is approved for all adalimumab indications.
Fresenius Kabi launches Idacio® (biosimilar adalimumab) in Canada
Fresenius Kabi announced it has launched Idacio® (biosimilar adalimumab) in Canada. Idacio® is available in 50mg/ml formulation (40mg/0.8mL syringe, vial and pen presentations) and is approved for all Humira® indications.
Sandoz launches Hyrimoz® (biosimilar adalimumab) in Canada
Sandoz announced that it has launched Hyrimoz®, its 50mg/mL biosimilar adalimumab in Canada. Hyrimoz® was approved by Health Canada in November 2020 with a full label. It was also previously launched in Europe in 2018.
FDA accepts Coherus’ BLA for biosimilar adalimumab
Coherus Biosciences announced the FDA has accepted the BLA for its biosimilar adalimumab candidate (CHS-1420). Coherus also announced that it plans to launch its product in the US on or after 01 July 2023. Coherus had previously disclosed that its license with AbbVie would commence in the US in December 2023.
Fujifilm and Mylan launch Hulio® (biosimilar adalimumab) in Japan
Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.
Celltrion’s Yuflyma® (biosimilar adalimumab) approved in the EU
Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.
Celltrion discusses its adalimumab biosimilar
In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.
Vizient releases Pharmacy Market Outlook
Celltrion receives positive opinion from CHMP for Yuflyma®(biosimilar adalimumab)
Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. If approved, this will be the first registered high concentration, citrate-free adalimumab biosimilar anywhere in the world.
China’s NMPA approves Henlius’ adalimumab
Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
Novartis provides updates on Sandoz biosimilar candidates
Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.
Health Canada grants NOC for Hulio®
BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).
EMA and FDA accept Alvotech’s adalimumab application
Alvotech announces the FDA and EMA have accepted its regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.
Health Canada issues NOCs for Amgevita®
Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).
Celltrion announces results of Ph III trials of proposed AmAb biosimilar
Celltrion announces the results of Ph III studies of CT-P17 (proposed adalimumab biosimilar) demonstrate comparable efficacy and safety against reference adalimumab in rheumatoid arthritis.
Health Canada issues NOC for Idacio®
Fresenius Kabi receives a Notice of Compliance relating to its biosimilar adalimumab (50mg/mL), Idacio®.
Two amicus briefs filed in support of Humira® antitrust legislation
Two amicus briefs were filed in the 7th Circuit Court of Appeals in support of the plaintiffs in the Humira® (adalimumab) antitrust legislation UFCW Local 1500 Welfare Fund v AbbVie, Inc. The US Public Interest Research Group jointly filed its brief with Consumer Action, arguing that AbbVie’s conduct was anticompetitive, and that the District Court’s decision should be overturned. In its brief, the Open Markets Institute argued that the District Court should have evaluated AbbVie’s patent applications and lawsuits as a series of sham filings.
Oxford commences Ph II AmAb trials in COVID-19 patients
The University of Oxford announces it has commenced Ph II trials of adalimumab as a treatment for patients with COVID-19. The trial will enrol up to 750 patients from community care settings throughout the UK and is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome and Mastercard. The trial will assess Hyrimoz® (biosimilar adalimumab), developed by Sandoz.
China’s NMPA approves Sulinno®
Innovent Biologics announces China’s NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.
Cadila launches Cadalimab® in India
Cadila Pharmaceuticals launches Cadalimab® (biosimilar adalimumab) in India. Cadalimab® is available in 40mg/0.8mL injection and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. This is the fourth biosimilar launch in India by Cadila within 2 months following Bevaro® (biosimilar bevacizumab), Ritucad® (biosimilar rituximab) and NuPTH® (biosimilar teriparatide).
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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