Biocon Joins Fray For Denosumab, Ustekinumab Biosimilars

Eylea Biosimilar Option Exercised

Biocon is progressing trials for biosimilar rivals to Amgen’s Prolia/Xgeva (denosumab) and J&J’s Stelara (ustekinumab), even as it gears for other large opportunities coming its way via the Viatris deal including for blockbusters Humira and Eylea.

partnering
Biocon Projects Robust Growth Outlook • Source: Alamy

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 "

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Business

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By 

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By 

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Roche Reveals Another US Manufacturing Site As Tariff Pressures Seem To Ease

 
• By 

Roche/Genentech unveiled plans for a $700m-plus manufacturing facility for weight loss drugs in North Carolina as President Trump signaled such investments could mean no tariffs for pharma.

Trump’s MFN Executive Order More Rhetoric Than Action

 

The details of Trump’s latest executive order on drug pricing are vague and the president put more blame on other countries and pharma distributors than drug companies.

More from Scrip

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Trump’s MFN Executive Order More Rhetoric Than Action

 

The details of Trump’s latest executive order on drug pricing are vague and the president put more blame on other countries and pharma distributors than drug companies.

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.