Pearce IP BioBlast™: w/e 25 September 2020

by , | Sep 28, 2020

Significant biosimilar activities this week include

21 Sep 20 | EU | Alexion announced it has received a positive opinion from the EU’s CHMP for a new 100mg/mL formulation of Ultomiris® (ravulizumab).  The new formulation requires an infusion time of 0.4 hours to 1.3 hours depending on body weight, which is less than half of the required infusion time for the current 10mg/mL formulation.

22 Sep 20 | Alvotech announced an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data.. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.

24 Sep 20 | Accord Healthcare launched Zercepac® (biosimilar trastuzumab) in the UK.  Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.

24 Sep 20 | The International Generic and Biosimilar Medicines Association (IGBA) released a new policy paper which calls for the streamlining of biosimilar regulatory requirements, and renewed efforts in informing and educating healthcare community stakeholders.

25 Sep 20 | JP | Alexion announced it has received approval in Japan for an additional indication of Ultomiris® (ravulizumab). Ultomiris® is now also indicated for atypical hemolytic uremic syndrome in adults and children.

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