Amol Akhade, Senior Consultant at Fortis Hospitals Mumbai, shared a post on LinkedIn about a paper he co-authored with colleagues, published in The Lancet Oncology:
“Subcutaneous Immunotherapy – A Wolf in Sheep’s Clothing?
Published in The Lancet Oncology (Nov 2025)
Authors: Dr Daniel A. Goldstein, Dr Roni Levin, Dr Manju Sengar, Dr Amol Akhade (yours truly)
Over the past decade, oncology has witnessed a steady migration of drugs from intravenous (IV) to subcutaneous (SC) administration – from rituximab and trastuzumab to newer immunotherapies like nivolumab and pembrolizumab.
The reasons seem obvious: shorter chair time, easier logistics, happier patients.
But are these changes always as innocent as they appear?
Our recent Lancet Oncology essay titled ‘Subcutaneous Immunotherapy – A Wolf in Sheep’s Clothing?’ takes a closer look at this shift.
Convenience vs Consequence
SC immunotherapy offers clear logistical and patient benefits – rapid injections, reduced nursing time, and fewer hospital visits.
However, as the essay explores, the timing of these new formulations often coincides suspiciously with the expiry of original IV patents.
This strategy, known as ‘evergreening’ or ‘product hopping,’ allows companies to extend market exclusivity by introducing a slightly modified formulation (for example, changing the route of administration).
The result?
The SC versions stay protected by new patents while IV biosimilars – which could make treatment dramatically cheaper – are delayed or sidelined by market preference.
What the data show
Clinical trials confirm that subcutaneous versions of checkpoint inhibitors like nivolumab, pembrolizumab, and atezolizumab have:
- Equivalent efficacy
- Comparable safety
- Greater patient convenience
Yet the global sales data are staggering – pembrolizumab alone generated USD 29 billion in 2024, and over USD 7 billion in Q1 2025.
Even a modest delay in biosimilar competition represents billions in potential savings lost for health systems worldwide, particularly in low- and middle-income countries struggling with access and affordability.
The bigger picture
This essay is not an argument against innovation – it is a call for balance.
Innovation should not just repackage the same molecule under a new patent; it should meaningfully improve patient outcomes or system efficiency.
Otherwise, we risk confusing convenience with progress.
As the authors note, ‘Although the increased convenience from subcutaneous immunotherapy is real, it may be outweighed by the long-term cost of suboptimal biosimilar adoption.’
Why this matters
For oncologists and health economists alike, the debate goes beyond pharmacokinetics – it’s about equity, ethics, and economics.
Each time a new ‘convenient’ formulation enters the market, we must ask:
- Does it truly benefit patients, or primarily extend patient life?
- Does it improve access in LMICs, or widen disparities?”
Title: Subcutaneous immunotherapy – a wolf in sheep’s clothing?
Authors: Roni Levin, Amol Akhade, Manju Sengar, Daniel A Goldstein
You can read the Full Article in The Lancet Oncology.
More posts featuring Amol Akhade.