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Shanghai Biomabs commences Ph I trials of biosimilar denosumab candidate.

Study reveals outcomes for the use of filgrastim in stem cell mobilisation prior to transplant, recording similar outcomes for tbo-filgrastim, the reference drug and biosimilar filgrastim (Zarxio).

FDA approves Pfizer’s bevacizumab biosimilar, Zirabev® for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent gliobastoma; metastatic renal cell carcinoma; and persi...

The CHMP recommended an extension of the approval of Dupixent® (dupilumab) to also include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent was first approved by the EC in September 2017.

AbbVie announces agreement for the acquisition of Allergan for $63 billion in a cash and stock exchange.

Henlius announces that EMA has accepted Henlius’ MAA for trastuzumab biosimilar HLX02. This is the first Chinese developed TmAb biosimilar to be accepted for review by the EMA.

Sandoz announces results of Hyrimoz® switching studies in patients with moderate-to-severe rheumatoid arthritis, announcing no clinically meaningful differences in safety, efficacy or immunogenicity.

FDA approves Amgen’s biosimilar TmAb Kanjinti® for all indications.

FDA accepts Roche’s BLA and grants priority review to Rituxan® for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children. The FDA is yet to approve any treatments for these blood vessel disorders.

Samsung BioLogics announces Imraldi® dominates 46% share in European adalimumab biosimilar market.