Shots:

• The MAA submission of the MSB11455 includes the results of two pivotal clinical trials including bioequivalent PK & PD data with similar immunogenicity results and includes analytical plus safety data which was comparable to pegfilgrastim
• Fresenius Kabi’s attempt to submit MAA is another milestone following last year’s approval and launch of the company’s adalimumab biosimilar in EU and plans for the expansion of therapies in oncology and life-threatening diseases
• MSB11455 is recombinant human GCSF which helps in stimulation of white blood cell and is developed by Fresenius Kabi’s biosimilars team based in Switzerland. Neulasta is a reference product approved for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy in the EU

Click here ­to­ read full press release/ article | Ref: Fresenius Kabi | Image: Behance