• Naomi Pearce

Pearce IP BioBlast: w/e 11 December 2020

Significant biosimilar activities this week include:

  • 07 Dec 20, CN: Shanghai Henlius Biotech announced its adalimumab biosimilar HLX03 has been approved by China's NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

  • 08 Dec 20: a new long-term efficacy and safety study demonstrated the biosimilarity of Celltrion's CT-P10/Truxima® (infliximab) to Rituxan® at 27 months in patients with low-tumor burden follicular lymphoma.

  • 08 Dec 20: Agilent awarded Prof. Anurag Rathore an Agilent Thought Leader Award for his contributions to the field of biopharmaceutical research and his work with advanced methods for molecular characterisation of biosimilars.

  • 09 Dec 20: a new study indicated Intas Pharma's romiplostim biosimilar Romy® has demonstrated a high overall response rate without adverse events in patients with immune thrombocytopenic purpura. Romy® has been approved in India.

  • 10 Dec 20, JP: Alvotech and Fuji Pharma announced they have agreed on an extension of their exclusive strategic partnership for the commercialisation of four biosimilar medicines in Japan.

  • 10 Dec 20, EU: Celltrion received 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.

  • 10 Dec 20, EU: Merck received a positive opinion from the EU's CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

  • 11 Dec 20: Innovent announced the first patient has been dosed in its Ph II trials of IBI310 (anti CTLA-4 monoclonal antibody) in combination with Tyvyt® (sintilimab) for the treatment of second-line or above advanced cervical cancer.

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