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Significant biosimilar activities this week include
11 Aug 20 | In an online press conference, Samsung Biologics announced it plans  for a fourth manufacturing plant within the year.  This new US $2 billion plant will have 256KL capacity, with manufacturing activities...

Lupin and Mylan launch Nepexto® (biosimilar etanercept) in Germany. Nepexto® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, severe axial spondyloarthritis and plaque psoriasis.

Bio-Thera Solutions and BeiGene announce they have executed a license / distribution and supply agreement for BAT1706 (proposed bevacizumab biosimilar). Subject to approval by Bio-Thera’s shareholders in September, the agreement grants BeiGene the right to develop, ma...

MSD announces Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

new indication for the treatment of patients whose tumours are PD-L1-positive, and have radically unresectable, advanced or rec...

Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

PBS publishes the outcomes of the July 2020 meeting including a positive recommendation for Merck’s application to broaden out the PBS reimbursed indications for its Hadlima® (biosimilar adalimumab). Merck’s Hadlima® was first granted PBS listing in 2018 for rheumatoid arth...

Intract Pharma and Celltrion announce an agreement to jointly develop the world’s first oral antibody therapeutic for the treatment of IBD. The infliximab product has been cleared by the UK’s MHRA to proceed to Ph 1b/2a clinical trials in patients with IBD durin...

Samsung Bioepis announces that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung’s application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Sa...

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020...