Dec 1, 2017 was a historic day for Biocon. Late on Friday night, Biocon announced that its biosimilar Trastuzumab has become the first biosimilar from India to be approved in the US.
Ogivri™, a biosimilar Trastuzumab co-developed with Mylan, received US FDA approval on Friday for all indications included in the label of the reference product, Herceptin®, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.
Not only is Ogivri™ the first biosimilar Trastuzumab to be approved in the US, it is the first biosimilar from India to be approved in the US.
“The US FDA approval for our biosimilar Trastuzumab is the result of a 10-year journey of self-belief; a journey of endurance; a journey of building credibility,” Biocon CMD Kiran Mazumdar-Shaw said in an address to Biocon employees on Monday.
“We have demonstrated that we are a credible biopharmaceutical company from India that can compete with the best in the world,” she added.
Whilst accolades poured in from external stakeholders over the weekend, the media was also ecstatic about this landmark achievement from Biocon.
Here’s a collection of what some of the leading media outlets from India and overseas had to say about Biocon reaching this major milestone.
“Perhaps in the global (biosimilars) market, the time has come for all unwelcome guests to leave the party… The chairs on the deck are rearranging. And Biocon finally has a seat at the high table.”
Seema Singh (The Ken)
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“For 64-year Kiran Mazumdar-Shaw, the maverick leader of Biocon, the USFDA approval of biosimilar Herceptin is a vindication of her foresight and perseverance to stay invested in biosimilars where the risk of failure is high and pay-off takes many years.”
Viswanath Pilla (MoneyControl.com)
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“While Biocon’s shareholders should temper their enthusiasm, as the launch is expected only in 2019, they too can take comfort from the boost to the company’s credibility as well. These credentials not only matter for valuations but also for when Biocon may negotiate partnerships for its other under-development products.”
Ravi Ananthanarayanan (Mint)
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“The US Food and Drug Administration’s approval is a significant move for the Kiran Mazumdar-Shaw-led company, which has charted a different growth path from other Indian drug makers.”
Aneesh Phadnis (Business Standard)
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“This comes as a sign of validation of its long-chased dream of gaining feet in this highly complex (biosimilars) science.”
Divya Rajagopal (Economic Times)
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“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
US FDA News Release
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“The FDA said Mylan’s drug Ogivri, which was co-developed with India’s Biocon, was the first biosimilar approved in the United States to treat breast or stomach cancer.”
Reuters
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“Mylan and Biocon today became the first drugmakers to win an FDA approval of a biosimilar of Roche’s blockbuster cancer drug Herceptin, a med that raked in $2.5 billion in U.S. sales last year.”
Eric Palmer (FiercePharma)
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“The savings of putting people on far less costly biosimilars – even just new patients who have never taken the original – are estimated to be billions of dollars.”
Lydia Ramsey (BusinessInsider.in)
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