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PBAC Committee recommends all 4 brands of Celltrion biosimilar products (Tuxella®, Rituzena®, Ritemvia®, Truxima) for PBS listing in AU for all TGA registered indications for which the reference brand Mabthera is currently listed on the PBS, despite approved skinny label). ...

Roche announces EC approval for a label expansion of MabThera®. The approval now includes the treatment of pemphigus vulgaris, the first major advancement for the treatment of this disease in more than 60 years.

UK Competition and Markets Authority closes investigation into MSD discount scheme after finding no grounds for further action. This decision is contrary to the provisional findings in May 2017 which indicated a breach of competition law.

Alvotech commences Phase III trial of 100mg/mL adalimumab biosimilar. 400 participants will be enrolled across 30 sites in Europe in this comparability study.

Pfizer announces FDA approval of biosimilar trastuzumab Trazimera® for the treatment of HER2 positive breast cancer and HER2 metastic gastric or gastroesophageal junction adenocarcinoma.

Celltrion claims results of 1 year comparison study of subcutaneous formulation of infliximab biosimilar demonstrate comparable efficacy and safety with intravenous formulation.

Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.

Sandoz obtains Sandoz Australian approval for biosimilar adalimumab Hyrimoz®. This is the third biosimilar adalimumab approval in Australia.

Celltrion gains Australian approval for biosimilar rituximab under two product names, Rituzena® and Tuxella®.

Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.