On track for launching Semglee in US in Q2FY21: Biocon’s Kiran Mazumdar Shaw
Biocon and its Mylan today received the US FDA’s approval for their insulin glargine injection Semglee, used for Type 1 and Type 2 diabetes.
Biocon and its Mylan today received the US FDA’s approval for their insulin glargine injection Semglee, used for Type 1 and Type 2 diabetes.
The nod comes through soon after the US Patent and Trademark Appeal Board (PTAB) rejected a challenge from Sanofi, which said Semglee infringes upon the patents for its product Lantus, also an insulin glargine injection.
“All the decks are cleared, we have won all the pending litigations. That paves the way for an unencumbered entry into the US market,” Biocon CMD Kiran Mazumdar Shaw told CNBC-TV18. “We already said that we were going to launch in Q2 of this fiscal and we are on track for that,” she further mentioned.
“We have already been approved in Europe but entering the US market was extremely important for Biocon. So we believe that this could now open the way to a very large business opportunity for Biocon in the years ahead,” she said.
Shaw added that glargine was a $8 billion market globally, with the majority of it being in the US.
“We are confident that we will get a very decent double-digit plus market share in the US before long. The US opportunity is about USD 6-7 billion,” she said.
The Biocon chief also talked about the COVID-19 pandemic, saying the government must focus on bringing down the mortality rate.
She added that the economy could not afford another lockdown and it would not help also.
“Implementing a lockdown
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