06 April 2021 | PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.
06 April 2021 | US | The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.
07 April 2021 | CA | British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.
07 April 2021 | Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.
08 April 2021 | Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.
08 April 2021 | Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.