Pearce IP BioBlast: w/e 10 Apr 2020

Significant biosimilar activities this week include:

• At the end of March, BiosanaPharma released the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.

• On 06 April 2020, the International Generic and Biosimilar Medicines Association (IGBA) called for urgent priority designation for medicines at custom controls for cargo and freight during the CoVid-19 pandemic. In particular, IGBA highlighted the need for ICU medicines and the goods needed to manufacture them to be moved at greater speeds through 'green lanes' .

• On 08 April 2020, NeuClone Pharma announced it had completed monitoring visits and blood sampling for Ph I trials of NeuLara (ustekinumab).

• On 08 April 2020, Pfizer announced FDA had approved Braftovi® (encorafenib) in combination with Erbitux® (cetuximab) for the treatment of BRAF600E-mutant metastatic colorectal cancer after prior therapy.