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On 4 March 2021, the Australian TGA approved Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, as well as Crohn’s disease, ulcerative colitis...

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 injecti...

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 agreemen...

Pharmaceutical Technology reported AbbVie’s intended Humira® follow on Rinvoq® (upadacitinib) may face questions on class safety after a safety signal emerged in a postmarketing trial of Pfizer’s Xeljanz® (tofacitinib). Tofacitinib and upadacitinib are both JAK ...

Samsung Bioepis commenced Ph I trials for SB11 (proposed ustekinumab biosimilar).

Biocon Biologics and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abevmy® will be available for the treatment of metastatic colorectal carcinoma, metastatic breast can...

The FDA extended the indications of Simponi Aria® (golimumab) to include fatigue in patients with psoriatic arthritis and rheumatoid arthritis. This is the first TNF inhibitor approved to include fatigue improvement in its labeling.

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 biosimil...

Minnesota State Senator Carla Nelson (R-Rochester) and State Representative Jennifer Schultz (DFL-Duluth) announced the introduction of a new bill which would require health plans and pharmacy benefit managers to cover all versions of biosimilars.