• U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars
  • U.S. Food & Drug Administration approves a second infliximab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales

  • European Medicines Agency newly approves two adalimumab biosimilars
  • U.S. Food & Drug Administration approves first bevacizumab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales for the top nine branded biologic

  • European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of adalimumab biosimilar
  • U.S. Food & Drug Administration approves second adalimumab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the

Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab), to the Food and Drug Administration (“FDA”).  According to the press release, Amgen and Allegan have “formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines.”

Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019)

The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license application (BLA 125646) for tisagenlecleucel (CTL019), an investigational chimeric antigen receptor T cell (“CAR-T”) therapy.  Novartis is seeking approval of CTL019 for the treatment of patients from

Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s Rituxan® (rituximab), has been accepted for review by the Food and Drug Administration (“FDA”).  The FDA is expected to act on the application in the first quarter of 2018.

Rituximab is an anti-CD20 monoclonal antibody approved for

On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s Rituxan®/Mabthera®.  The approval follows the positive recommendation by the Committee for Medicinal Products for Human Use (“CHMP”) issued two months ago.

Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large