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Genentech announced that the FDA has accepted the BLA for its Port Delivery System (PDS) with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

Taiwan-based Synermore Biologics is recruiting participants for a study to be conducted in Europe and Russia to compare SYN008 and Xolair for the treatment of chronic urticaria not well controlled by antihistamines.

Nichi-Iko announced it has entered a licence and supply agreement with Laboratorio Elea Phoenix for a biosimilar infliximab product. Under the agreement Nichi-Iko will supply the product to Elea for the Argentine market.

Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.

Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.

Celltrion presented data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress. Celltrion reported that the response rates, survival rates and overall safety profile of Truxima® appeared consistent with those rep...