Tags : Australia

JHL Biotech Reports Dosing of its First Patient with JHL1266

Shots: The study involves assessing of JHL1266 vs Prolia sourced from the EU and the US in healthy human subjects evaluating its PK, PD, and immunogenicity The JHL1266 is proved to be a milestone and an initiative in bringing safe, effective, and high-quality biologics JHL1266 is a mAb targeting RANKL works by inhibition of developed […]Read More

CEPI Collaborates with Clover to Support the Development of Vaccine

Shots: CEPI to invest $3.5M in Clover to support the initiation of P-I clinical study of its protein-based COVID-19 S-Trimer vaccine in Australia. The vaccine is based on Clover’s Trimer-Tag vaccine technology platform, used to produce the spike proteins of the COVID-19 virus in a native trimeric form for use in a vaccine The collaboration […]Read More

Biocon and Mylan Launch Fulphila (biosimilar, Pegfilgrastim) in Australia

Shots: The companies launched Fulphila, a biosimilar referencing Neulasta (pegfilgrastim) in Australia. The biosimilar received TGA’s approval to treat cancer patients following the CT, to decrease the duration of neutropenia and to reduce the incidence of infections, as manifested by febrile neutropenia The approval is based on analytical, clinical and nonclinical data which demonstrated that […]Read More

Celltrion Signs an Exclusive Co-Marketing Agreement with Juno in Australia

Shots: Juno to provide sales promotion and hospital contracting services to Australian Hospital market customers and will co-market Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab) with Celltrion in Australia  The focus of the agreement is to market globally biosimilar brands to Australian Healthcare professionals and patients Herzuma (CT-P6, biosimilar, trastuzumab) is a mAb targeting the […]Read More

Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in Australia

Shots: Ogivri is the first biosimilar to Herceptin (trastuzumab) to be approved and launched in Australia for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer and will be available on the Pharmaceutical Benefits Scheme The TGA’s approval of Ogivri is based on data which demonstrated bio-similarity to Herceptin with no clinically meaningful differences […]Read More

Celltrion’s Herzuma (Herceptin biosimilar) Receives Marketing Approval in Australia

Shots: Herzuma is first biosimilar approved in Australia for the treatment of early breast cancer, locally advanced or metastatic or advance gastric cancer Including Herzuma Celltrion has three biosimilar for Australia, Remsima for autoimmune disease, Truxima for blood cancer approved in Aug 2015 and April 2018 respectively Celltrion plans to launch Herzuma in Australia after […]Read More