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Celltrion releases its Q2 FY20 earnings report.  Celltrion reported that it is “preparing” its US approval application for CT-P17 (biosimilar adalimumab candidate), following the filing of its application in the EU in March this year. 

Alvotech and Teva announce a strategic partnership to collaborate on five biosimilar product candidates in the US market. Under the agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commer...

In its Q4 FY20 earnings call, Aurobindo Pharma announced that its wholly owned subsidiary CuraTeQ Biologics intends to file applications for two of its biosimilar products in EU at the end of 2020 or start of 2021, with target EU launches following one year later. Aurobindo...

Celltrion gains WHO prequalification for its trastuzumab biosimilar Herzuma®. The prequalification status enables Celltrion to make a bid in global procurement by UN agencies, and is based on an evaluation of safety and efficacy.

Significant biosimilar activities this week include
27 Jul 20 | EU | Celltrion announced the European Commission has granted marketing authorisation for Remsima® (biosimilar infliximab) subcutaneous formulation for the treatment of adult patients with ankylosing spond...

Vizient has advised its member health groups to utilise biosimilars to hedge against drug price inflation and the impacts of COVID-19. Vizient predicts that drug prices in the US will increase by 3.29% in 2021.

Janssen announces the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.

Cadila Pharmaceuticals announces it has launched Ritucad® (biosimilar rituximab). Ritucad® has been approved for Non-Hodgkin’s Lymphoma and rheumatoid arthritis. This follows Cadila’s launch of Bevaro® (biosimilar bevacizumab) in India last week.

Shanghai Henlius Biotech and Accord Healthcare jointly announce the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer...

Pfizer releases its Q2 FY20 financial results. Pfizer reported a 16% decrease in international revenues for Enbrel® (etanercept), attributing this decrease to biosimilar competition in Europe, Japan and Brazil.