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Momenta announces a shift in focus from biosimilars to novel therapeutics. The 5 year re-structuring plan will involve cuts to staff of 50%, however the company will continue to develop biosimilar aflibercept candidate M710.

Momenta announces an end to its strategic review, revealing a sole focus to advance a Humira® biosimilar. Momenta announced it will file a BLA with the FDA and is working to find a commercialisation partner for the product. 

FDA accepts BLA for biosimilar adalimumab. 

Mylan announces the EU approval of Hulio®, biosimilar adalimumab licensed from Fujifilm in April 2018.

Researchers release results of pre-clinical study of cetuximab candidate APZ001. 

FDA announces approval of Amgen’s Mvasi®, the first BmAb biosimilar to gain approval in the US

Significant increase in the use of alternative filgrastim products reported among Medicare Part B beneficiaries.

Iranian AryoGen receives GMP certification from the European Medicines Agency, becoming the first mAb manufacturer in the Middle East and North Africa region to do so. 

Bio-Thera announces that the CNDA (China National Drug Administration) has accepted its BLA for biosimilar adalimumab BAT1406.  This is expected to be Bio-Thera’s first drug approval.

Pfizer accuses originators of using scare campaigns to undermine confidence in biosimilars in a citizen’s petition seeking guidance on the representations which can be made about biosimilar products. Pfizer criticises the slower uptake of biosimilars in the US in comp...