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Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA ...

Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).

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...