Mylan announced the launch of their trastuzumab biosimilar at the end of 2019. Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 (HER2)-receptor positive breast cancer, previously marketed by Genentech as Herceptin. Mylan’s biosimilar version is named Ogivri and has been co-developed with Indian pharmaceutical company Biocon Biologics.

Ogivri was the first trastuzumab biosimilar approved by the US Food and Drug Administration (FDA) back in December 2017 [1]. The product will be available in two dosage forms (150 mg single-dose vial and 420 mg multi-dose vial) and is licensed for the treatment of breast and gastric cancer.

The approval was based on data demonstrating no clinically meaningful differences between Ogivri and Herceptin in terms of safety, purity and potency. Results from the study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Although it was the first biosimilar approved, Ogivri is second to launch on the market. It follows Amgen’s biosimilar Kanjinti, which was launched on the US market in July 2019, just after its approval by FDA in June 2019 [2].

Mylan’s President Rajiv Malik said that the launch ‘has been achieved through years of hard work as a result of our successful collaboration with Biocon. Our early settlement and license with Roche to bring this product to market allows us to launch Ogivri without legal risk.’

Dr Christiane Hamacher, CEO of Biocon Biologics, said the launch is a ‘significant milestone’ in the company’s biosimilars journey. She added that the launch ‘is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420 mg multi-use vials and 150 mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the US.’

The companies say the drug will be launched at ‘a competitive discount’ to help ensure access for patients, although they did not state the list price.

Related articles
Mylan launches first trastuzumab biosimilar in Australia

FDA approves trastuzumab biosimilar Kanjinti

Mylan gains nod for Ogivri and launches Hulio in Europe

FDA rejects Amgen’s trastuzumab biosimilar

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