Biosimilars

Teva and Alvotech Collaborate to Commercialize Five Biosimilar Candidates in the US

August 5, 2020August 5, 2020Tuba Khan

Shots: Alvotech will lead the development, registration, and supply of the biosimilars, while Teva will be exclusively commercializing the products in the US. [Read More...]

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02 (biosimilar, trastuzumab)

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of [Read More...]

Cadila to Launch its Ritucad (rituximab, biosimilar) in India

July 29, 2020August 5, 2020Shiwani Sharma

Shots: Ritucad is the second biosimilar in Cadila’s portfolio of biosimilars and will be available in a single-dose vial of two strengths, 100 [Read More...]

Celltrion Reports Submission of MAA to EMA for CT-P17 (biosimilar, adalimumab)

Celltrion’s Remsima SC (infliximab, CT-P13) Receives the EC’s MAA for Additional Five Indications

July 27, 2020August 5, 2020Shiwani Sharma

The approval follows the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with [Read More...]

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

July 27, 2020July 27, 2020Tuba Khan

Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat [Read More...]