BioBlast®

Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta^® (pertuzumab, HLX11) and Prolia^®/Xgeva^® (denosumab, HLX14).  Under the agreement, Organon has exclusive global commercialisation rights “except for China; including Hong Kong, Macau and Taiwan”.  The agreement also includes an option for an exclusive licence for global commercialisation rights to a biosimilar to BMS’ Yervoy® (ipilimumab).

A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar trastuzumab) and pertuzumab administered as an admixture in a single infusion bag is consistent with what is known for reference trastuzumab and pertuzumab.

Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.

In its final appraisal of pertuzumab, the National Institute for Health and Care Excellence (NICE) has recommended it for the treatment of lympth node-positive disease. The final appraisal comes following the promise of a large discount offered by Roche.

NeuClone announces that it has biosimilar pertuzumab in preclinical development.

The National Institute for Health and Care Excellence (NICE) again recommends against Roche’s application for pertuzumab as an adjuvant treatment in patients with a high risk of recurrence. NICE confirmed its earlier findings that pertuzumab is unlikely to be cost-effective, with clinical trials revealing only a small incremental treatment benefit.

The National Institute for Health and Care Excellence (NICE) rejects pertuzumab for adjuvant treatment of early breast cancer. The draft guidance reports that the drug may not extend patient’s lives and is not cost effective.

Biocon announces Biocon and Mylan add insulin glargine 300 and pertuzumab to their collaboration.