Read our latest updates & insights

Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).

Samsung Biologics began construction of the world’s largest biopharmaceutical manufacturing facility in Incheon, South Korea. The plant is expected to commence operations by the end of 2022, and to be fully operational from 2023.

The International Generic and Biosimilar Medicines Association (IGBA) launched the first Global Biosimilars Week.

Significant biosimilar activities this week include
05 Nov 20 | Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, which Formycon an...

CSL’s Sequiris announced it will build a next-generation $800 million influenza vaccine manufacturing facility in Australia. The facility is expected to be operational by mid-2026 and will be the only cell-based influenza vaccine manufacturing facility in the Southern...

Genentech files a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin relating to its proposed bevacizumab biosimilar. Genentech asserts that Centus failed to provide sufficient information for Genentech to complete an ana...

PM Scott Morrison announced the National Cabinet has endorsed a national vaccination policy. The policy focusses on five key areas; R&D, purchase and manufacturing, international partnerships, regulation and safety and immunisation administration and monitoring.

The CHMP adopts a positive opinion for the marketing approval for Samsung Bioepis’ Onbevzi® (biosimilar bevacizumab). Onbevzi® will be available as a 25mg/mL concentrate for solution for infusion, and is indicated for the treatment of carcinoma or the colon or rectum,...

The TGA approves Celltrion’s subcutaneous “biobetter” infliximab product Remsima® in auto-injection pen and PFS presentations. This is the first subcut infliximab product to be approved in Australia.