Biocon, Ltd. expects to build on portfolio gains and commercial capabilities in developed markets via the Viatris Inc. biosimilars transaction, with its vaccines alliance with Serum Institute of India Pvt. Ltd. driving new growth opportunities alongside. Two “unpartnered” assets - denosumab and ustekinumab biosimilars – have also moved into clinical trials, expanding pipeline promise.
Kiran Mazumdar-Shaw, chairperson, Biocon and Biocon Biologics, said that continued improvement in the performance of the existing portfolio, coupled with potential US launches of biosimilar aspart, bevacizumab, and adalimumab will enable the current Viatris-led business to deliver robust
Biosimilar Humira – ‘Room For Everyone To Play’
Biocon also provided some insights around the looming opportunity for biosimilar Humira (adalimumab), with the US launch expected in mid-2023. Biocon’s deal with Viatris covers the US firm’s in-licensed portfolio including adalimumab.
Biocon Biologics’ deputy CEO Shreehas Tambe confirmed that Viatris has been able to “secure” the citrate-free formulation of adalimumab and “the other thing is to see that we get the approval for all indications”.
“We're basically now looking at the other variables that are under discussion, whether it's the strength of the formulation, whether it's interchangeability to the device versus the syringe. These are conversations which are currently ongoing,” Tambe indicated.
While there are close to a dozen players expected to vie for the Humira biosimilar opportunity, Tambe underscored that with the pie being as sizable as it is, there is “room for almost every one to play”.
“If you were to look at what are we hearing from payers. I think there is still that wait and watch in terms of how the market is going to shape up to what is the offering that each player is going to bring to the market. But clearly, there is going to be ample opportunity for everyone to play because of the size of the opportunity,” he said in response to an analyst’s query on the earnings call.
In October last year, the US FDA approved Boehringer Ingelheim GmbH’s Cyltezo (adalimumab-adbm) as the first interchangeable Humira biosimilar.(Also see "First Interchangeable Humira Biosimilar Approved In US" - Generics Bulletin, 18 October, 2021.)(Also see "
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