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The WHO certifies Celltrion’s Truxima® (rituximab) in its prequalification program. This program assesses clinical and other data related to biosimilars, and aims to guide low-income countries in their selection of medicines, vaccines and technologies for national pro...

Pulse News reported that AProgen had doubled its production capacity with the addition of two new perfusion production lines, increasing total output capacity to 240,000 litres of culture fluid per cycle. AProgen currently has adalimumab, infliximab, trastuzumab, etanercept...

Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

Shanghai Henlius Biotech announces that China’s National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar. 

Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.

Shanghai Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

The American Journal of Managed Care reports two cost savings studies presented at a virtual meeting of the International Society for Pharmacoeconomics and Outcomes Research. The studies, which were sponsored by Pfizer, analysed the potential cost savings over a three year ...

Significant biosimilar activities this week include
11 May 20 | AstraZeneca announced it had recovered the global rights to brazikumab from Amgen. AstraZeneca had previously collaborated with Amgen to jointly develop and commercialise the product. Brazikumab is a mono...

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced its partner Biocon had received FDA pre-approval of its Malaysian manufacturing facility, as well as announcing a planned launch for Nepexto® (etanercept) in Europe within months.