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US gives nod to Biocon-Mylan's biosimilar of cancer drug Herceptin, revenues expected from FY19

In major breakthrough, Mylan and Biocon said that USFDA has approved Mylan’s Ogivri, a biosimilar to Swiss biotech giant Roche's blockbuster cancer drug Herceptin, co-developed with Biocon.


USFDA has approved Ogivri for all indications of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.
Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US.
"Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licences for its Trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan’s biosimilar to Herceptin in various markets globally," Biocon said in a statement.
Trastuzumab is the generic name of Herceptin, which has raked in USD 2.5 billion in US sales last year.
“The USFDA's approval for our biosimilar Trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar players," said Kiran Mazumdar Shaw, CMD of Biocon.
"It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world," Shaw added.
​For 64-year 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.
“This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies," said Arun Chandavarkar, CEO  and Joint MD, Biocon.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar for Herceptin is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
“We are proud to receive FDA approval of Ogivri, a biosimilar to Herceptin, as this further underscores the strength of our science team and our ability to execute science programs for hard-to- make and complex products like biosimilars," said Mylan President Rajiv Malik.
"Bringing such complex products to the market not only requires sound and robust science and a talented research and development team, but also the ability to manage legal and regulatory complexities and invest significantly in manufacturing capabilities," Malik added.
USFDA approval was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri to Herceptin.
The US FDA’s decision follows the unanimous vote by the FDA Oncologic Drugs Advisory Committee (ODAC) in July 2017 recommending approval of Mylan’s biosimilar to Herceptin.
Mylan and Biocon's biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India, thus providing increased access to this more affordable biologic for cancer patients.
​In the US an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone. Approximately 20 percent to 25 percent of primary breast cancers are HER2-positive.
​Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate a savings of USD 54 billion in direct spending on biologic drugs in the U.S. between 2017 and 2026.
"It's a watershed moment for Biocon," said Afzaal Mohammed, analyst tracking the company at Karvy said.
"The details of the launch were kept confidential at the moment, but we are expecting the drug to start generating to topline of Biocon from FY19," Mohammed said.
The news came after the Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted their resubmitted application for their Herceptin biosimilar, as well as for their copy of Amgen’s chemo drug, Neulasta. The agency accepted the new application after approving their plan to fix issues at the plant where the biosimilars are being made.
Analysts say with US FDA approval of biosimilar Herceptin it will be just a matter of time before EMA too giving its nod to the drug.



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