"It will allow us to bring this important biosimilar - the first of its kind - to market in the USA, expanding cancer-patient access to more affordable treatment".
The agency's commissioner, Scott Gottlieb, said that biosimilar approvals help "to promote competition that can lower health care costs".
The biosimilar's approval was based on a review of evidence including extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".
Shares of Biocon hit a one-year high in Monday's trade as the markets cheered after the USFDA validated its biosimilar cancer drug Trastuzumab and approved it for the USA market on Friday night.
But Ogivri also shares Herceptin's side effects, which can include heart disease (cardiomyopathy), infusion reactions, and lung damage, and it may also harm a developing fetus.
Mylan and Biocon's biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It will allow us to bring this important biosimilar, expanding cancer-patient access to more affordable treatment.
"We are extremely pleased with the acceptance of our [marketing authorization application in Europe]", Rajiv Malik, Mylan's president, said in a press release. Ogivri is one of many biosimilars in our robust pipeline that we look forward to introducing in the coming years as part of our ongoing commitment to increasing access to important medicines for patients.
US Defence Secretary Mattis arrives in Pakistan
Qamar Javed Bajwa, separately, during his day-long visit, the second tour of a high profile USA official in less than a month. Asked if Mattis set any timelines, the official said the urgency of the matter was communicated.