Read our latest updates & insights

Australia’s TGA provisionally approved Roche’s Ronapreve™ (casirivimab and imdevimab) for two indications relating to COVID-19. Ronapreve™ is indicated for the treatment of COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased ri...

Bio-Thera Solutions announced it has reached a licensing and supply agreement with Pharmapark for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Pharmapark will have exclusive rights to distribute and market the product in Russia and other CIS countries.

Merck and Eisai announced that the CHMP has adopted positive opinions recommending the approval of the combination of Keytruda® (pembrolizumab) plus Lenvima®/Kisplyz® (lenvatinib) for the first-line treatment of adults with advanced renal cell cancer and for the treatment o...

Boehringer Ingelheim announced that FDA has approved Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab).   Cyltezo® is a 50 mg/mL “citrate free” (ie acetate buffered) product, and the “interchangeable” designatio...

Roche announced that the FDA has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer whose tumours express PD-L1≥1%.

Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin glargine biosimilar.

Merck announced that the FDA has approved Keytruda® (pembrolizumab) plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

The Korea Herald announced that Celltrion has submitted a Marketing Authorisation Application to the EMA for CT-P16 (proposed bevacizumab biosimilar).