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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...

Qilu commences Ph 1 trials of biosimilar denosumab candidate.

Nippon Kayaku launches Celltrion’s trastuzumab biosimilar in Japan, but only for the treatment of gastric cancers.

The National Institute for Health and Care Excellence (NICE) again recommends against Roche’s application for pertuzumab as an adjuvant treatment in patients with a high risk of recurrence. NICE confirmed its earlier findings that pertuzumab is unlikely to be cost-eff...