Biocon and its partner Mylan on December 2 announced the launch of Ogivri - a biosimilar to Herceptin - in USA.
Ogivri was the first biosimilar of Herceptin to be approved by USFDA two years ago, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. The drug was unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). However the launch of the drug was delayed due to a settlement with Roche.
"Our early settlement and license with Roche to bring this product to market allows us to launch Ogivri without legal risk," said Rajiv Malik, President, Mylan.
Ogivri, generically called as Trastuzumab, will be available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility.
The pricing details of Ogivri are immediately not available.
But Amgen-Allergan duo's which had launched their version of Trastuzumab under brand name Kanjinti at risk in July this year for the same indications, have priced the biosimilar 15 percent lower than the innovator product.
The list price of Kanjinti was made available at a list price of $1388.05 for 150 mg and $3697.26 per 420-mg multi-dose vial, according to Drugs.com. The prices were excluding rebates and coupons.
Roche, the innovator, had made $2.9 billion in 2018 on sales of Herceptin in the US.
Ogivri is the second biosimilar being commercialised by Mylan from Biocon's portfolio in the US market. Last year, through the duo launched Fulphila or biosimilar to Pegfilgrastim in US market.
Biocon and Mylan said they have sufficient manufacturing capacity to fulfil demand in the US and global markets for both products.
"The US launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey. We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of $1 billion by FY22," said Dr Christiane Hamacher, CEO, Biocon Biologics.
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