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’s Cyltezo (adalimumab-adbm) as the first interchangeable Humira biosimilar.(Also see "First Interchangeable Humira Biosimilar Approved In US" - Generics Bulletin, 18 October, 2021.)

Loss of exclusivity for AbbVie’s Humira, the largest in the history of the pharma market in the US, will bring in widely monitored biosimilar competition for anti-TNF biologics. Amgen’s Amjevita (adalimumab-atto) biosimilar is expected to launch on 31 January 2023, with several others in line to follow.(Also see "Humira One Year Out: The Largest LOE Event In US Pharma History" - Generics Bulletin, 31 January, 2022.)

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