Biosimilar drug by Mylan, Biocon gets USFDA approval

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MUMBAI: A decade-long partnership of US drug maker Mylan and Bengaluru-based BioconBSE 9.38 % saw the light at the end of tunnel as the US FDA granted marketing approval to its biosimilar drug Trastuzumab last Friday night. This ends the speculation over the drug’s launch. 

Trastuzumab branded as Ogivri is a version of Swiss drug maker Roche’s blockbuster breast cancer medicine that has become a standard therapy for treating the cancer causing HER 2 proteins. 

Biosimilar drugs are identical copy of highly complex biologic drugs that claim to have the same efficacy as that off the innovator’s version. 

With annual sales of $3.16 billion globally, Trastuzumab is expected to touch nearly $10 billion by 2020. 

Though the approval boosts Mylan’s numbers as the company has exclusive rights of selling these drugs in the US, for Biocon this comes as a sign of validation of its long-chased dream of gaining feet in this highly complex sc .. 

“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, MD. 

Indian markets had anticipated this approval for months now and analysts said that shares of Biocon will be reacting positively to this news. 

“The US FDA’s approval...is indeed a crowning moment that puts us in an exclusive league of global biosimilar players. It strengthens our resolve to focus on developing affordable biologics that can make cancer care more effective and equitable. It is an important milestone in our journey of developing advanced therapies that has the potential to benefit billions of patients,” said Kiran Mazumdar Shaw, MD, Biocon.