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US-Mexico-Canada Agreement includes 10 year exclusivity period for biologic drugs, raising concerns that competition will be hindered to the disadvantage of consumers and health services in those regions. Currently the exclusivity period stands at 8 years in Canada and 5 ye...

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.