(Health Korea News / Lee Chung-man) US BMS’s immune checkpoint inhibitor ‘Opdivo’ (ingredient name: nivolumab) is in the same class as MSD’s ‘Keytruda’ (ingredient name: pembrolizumab). They are trying their best to catch up, but they seem to be in a dilemma as they face an onslaught of biosimilars.
On the 15th (local time), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced that mismatch repair defect/high-frequency microsatellite instability (dMMR/MSI-H) patients with unresectable or metastatic colorectal cancer (mCRC) It was recommended to approve the combination therapy of ‘Opdivo’ and ‘Yervoy’ (ingredient name: Ipilimumab) as a treatment for .
Currently, among immune checkpoint inhibitors, ‘Keytruda’ is the only drug that has secured an indication for colon cancer treatment in Europe. The European Commission (EC) approved Keytruda as a treatment for colon cancer in January 2021.
Therefore, if ‘Opdivo’ is approved for expanded dMMR/MSI-H colon cancer indications, it is expected to become the second immune checkpoint inhibitor to obtain colon cancer indications in Europe, following ‘Keytruda’.
‘Opdivo’ is a drug that selectively acts on the PD-1 immune checkpoint protein, which inhibits the body’s immune response. It is a mechanism that induces the activity of the immune system by suppressing PD-1, thereby increasing cancer attack power.
The U.S. Food and Drug Administration (FDA) first approved ‘Opdivo’ in December 2014, the Korean Ministry of Food and Drug Safety in March 2015, and the EC in June 2015.
For reference, the Korean branch of Japan’s Ono Pharmaceutical Industries is in charge of the Korean release of ‘Opdivo’. Ono Pharmaceutical Industries secured exclusive rights to ‘Opdivo’ in Korea, Japan, and Taiwan by signing a contract with BMS in July 2014.
Since its launch, ‘Opdivo’ has emerged as a blockbuster drug by presenting a new paradigm in cancer treatment that overcomes side effects such as resistance and cytotoxicity compared to existing anticancer drugs. Sales in 2023 reached $9 billion (about KRW 12.5 trillion), ranking 11th in overall pharmaceutical sales and 3rd in anticancer drug sales.
However, in the anti-cancer drug market, it has been unable to shake off the tag of ‘second place for 10,000 years’ behind ‘Keytruda’. ‘Keytruda’ ranked first in overall pharmaceutical sales, generating profits of $25.011 billion (approximately KRW 34.85 trillion) in 2023.
This is partly because Keytruda was approved first, but the biggest factor is the difference in the number of indications. Across regulatory agencies around the world, there are 40 indications for ‘Keytruda’, while there are only 13 for ‘Opdivo’. This is why BMS is working to expand the indications for ‘Opdivo’.
However, the challenges of biosimilar companies are giving BMS another challenge.
The industry predicts that the exclusive sales rights for ‘Opdivo’ will expire before 2028 in Europe and after December 2028 in the United States. Companies are currently racing to develop later products in order to release similar products after that date.
As a result of this paper’s coverage, it was confirmed that there are eight biosimilars of ‘Opdivo’ currently under development. Among these, the most advanced are Amgen of the United States and Sandoz of Switzerland. The two companies are conducting phase 3 clinical trials evaluating ‘Opdivo’ biosimilars ‘ABP206’ and ‘JPB898’, respectively.
In Korea, Celltrion took up the challenge. It is known that Celltrion is currently developing materials for biosimilars.
As a result, there is an analysis that sales of ‘Opdivo’ will peak in 2028 and then turn to decline. Global Data, a market research company, predicted that sales of ‘Opdivo’ will hit $14 billion (about KRW 19 trillion) in 2028 and gradually decline thereafter.
$14 billion is slightly more than half of the $25 billion earned by ‘Keytruda’ last year. On the other hand, ‘Keytruda’ is expected to generate sales of a whopping $30 billion (about KRW 41.8 trillion) in 2028.
In the end, unless a miracle occurs, ‘Opdivo’ will never be able to overtake ‘Keytruda’ and will face an onslaught of biosimilars.
An industry official said, “From BMS’s perspective, the only way to reduce bleeding even a little is to aggressively expand the indications for ‘Opdivo’,” and added, “It appears that the expansion of indications for colon cancer in Europe is also part of this plan.”
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