Global Trastuzumab Biosimilar Market Analysis by Capital Investment, Industry Outlook, Growth Potential, Opportunities and Trends – Shanghaiist


A humanized monoclonal antibody made from recombinant DNA called tratuzumab binds to human epidermal growth factor receptor 2 (HER2). Trastuzumab is primarily intended for the treatment of HER2-positive breast cancer, but is also approved for the treatment of gastric cancer and metastatic breast cancer. Indeed, HER2 is excessively expressed in several types of breast cancer cells. Roche markets it under the Herceptin brand. It received approval from the European Medicines Agency in 2000 and from the United States Food and Drug Administration (FDA) in 1998. Trastuzumab, which controls more than 90% of the HER2-positive cancer market, has been Roche’s first targeted cancer drug. the world, trastuzumab, has improved survival rates and given people with HER2-positive breast cancer a better prognosis. Because Herceptin is so expensive, there is considerable desire for affordable drugs that can both meet the needs of patients with limited financial resources and expand program coverage. A biologic is considered biosimilar if it has clinical similarities to another biologic that has already received regulatory approval. Herceptin’s patent expired in Europe in 2014, in Asia in 2017, and in the United States in 2019. Trastuzumab biosimilars have therefore proliferated on the market. For example, the FDA cleared Allergan and Amgen’s biosimilar version of Herceptin for breast cancer in June 2019. Mylan NV announced Ogivri, a biosimilar to Herceptin (trastuzumab). The growth of the trastuzumab biosimilars market has been driven by the introduction of biosimilars in the market, an increase in the incidence and prevalence rate of breast and stomach cancers, increased demand for targeted therapies and price reductions. The trastuzumab biosimilar is expected to cost 80% less than Herceptin, making it more accessible and cheaper in low- and middle-income developing countries. However, the strict regulatory approval process for the trastuzumab biosimilar poses a significant barrier to market expansion.

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Amgen Inc.
Pfizer Inc.
Samsung Bioepis Co.
Merck & Co.
Biocon Limited
Mylan Inc.
BioXpress Therapeutics SA
EirGenix Inc.
Teva Pharmaceutical Industries Ltd.
Apotex (Apobiologix)
AryoGen Pharmad
Prestige BioPharma (PBP)
Plant Form
Therapeutic (Oncobiological) Outlook
Shanghai CP Guojian Pharmaceutical
Shanghai Henlius Biotech
and Stada Arzneimittel AG among others.

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Global Trastuzumab Biosimilar Market SegmentationGlobal Trastuzumab Biosimilar Market Outlook (Revenue, USD Million, 2019-2030) by Product
Other pipeline products

Global Trastuzumab Biosimilar Market Outlook (Revenue, USD Million, 2019 – 2030) by Indication
Adjuvant breast cancer
Metastatic breast cancer
Metastatic gastric cancer
Other indication

Global Trastuzumab Biosimilar Market Outlook (Revenue, USD Million, 2019 – 2030) by Distribution Channel
Hospital pharmacy
Online pharmacy
Other direct distribution channels

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