NEW DELHI :
Biocon Ltd and its partner Mylan on Monday announced the much-awaited launch of their biosimilar to oncology drug trastuzumab in the US under the brand Ogivri.
A biosimilar to F. Hoffman-La Roche's Herceptin that treats breast cancer and metastatic stomach cancer, Ogivri will be available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility.
"Biocon Biologics is committed to fulfil unmet patient needs by providing greater affordability for enhanced patient access. We aspire to serve 5 million patients
through our biosimilars portfolio and cross a revenue milestone of $1 billion by FY22," Biocon Biologics chief executive officer Christiane Hamacher was quoted as saying in the release.
In 2017, Ogivri was the first biosimilar trastuzumab approved by the US Food and Drug Administration
(FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC), as per a company release.
Ogivri is the second biosimilar being commercialized in the US from the partners' portfolio, following the launch of Fulphila, a biosimilar to another oncology drug pegfilgrastim.
The two partners had also gotten regulatory approval for the drug in India in 2014 but was stuck under patent litigation by Roche.
In 2017, Mylan signed an agreement with Roche and its subsidiary Genetech for the global licences of trastuzumab, paving the way for the biosimilar.
“Today’s 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," Mylan president Rajiv Malik was quoted as saying in the release.