Organon ‘Samsung’s Humira biosimilar to make KRW 100 billi

in the first year of its release in the US

Will release Hadlima in July...”Sales up to KRW 123.5 billion expected this year”

Approval as an interchangeable biosimilar expected by Q2 2024 in line with the approval of other competitors

Competition among biosimilars to start in earnest in 2024...” will rise as a leading product in the field”

Samsung Bioepeis’ U.S partner Organon projected that the sales of the company’s Humira biosimilar will reach a maximum of KRW 123.5 billion in the first year of its release.

 

On the 16th (local time), Organon projected so while presenting its full-year 2022 financial results, announcing that the company “will be launching the Humira biosimilar ‘Hadlima’ in the U.S.

 

July this year.” Hadlima is a Humira biosimilar that was developed by Samsung Bioepis.

 

Humira is a blockbuster drug that held the ranks as the most-sold drug worldwide for a decade.

 

Its global sales recorded USD 21.24 billion (approximately KRW 27 trillion) last year, of which sales in the U.S.

 

accounted for USD 18.62 billion (approximately KRW 24 trillion).

 

Starting with Amgen, various companies including Samsung Bioepis, Boehringer Ingelheim, Pfizer, and Coherus are set to release Humira biosimilars this year.

 

Amgen’s ‘Amjevita’ has already been released to the market.

 

In particular, up to 8 companies including Samsung Bioepis are expected to competitively release their biosimilar products in July this year.

 

Building on their successful launch of Hadlima in Canada and Australia, the company expects the experience to positively impact the launch in the U.S.

 

market.

 

Also, it pointed to Hadlima’s equal product composition and pen device technology as what differentiates its biosimilar from other products.

 

Organon said, “We have launched Hadlima in Canada and Australia in 2021 and achieved good results.

 

The data we collected from the launches will support our launch of the same in the U.S.

 

Both the citrate-free, high-concentration formulation and the low-concentration formulation will be released then.

 

The design of the pen that contains the drug can also be a differentiating factor.

 

As a device design and manufacturing expert, the company designed the pen to ensure a smooth transition for the patients switching from Humira to Hadlima.” Organon expects Hadlima to make sales of up to USD 96.75 million (KRW 123.5 billion) this year, the first year of its launch in the US.

 

This amount was derived based on the expectation that Hadlima sales will not exceed 1.5% of the estimated total sales of USD 92.25-96.75 million (KRW 117.8-123.5 billion), which roughly amounts to USD 92.25-96.75 million (KRW 117.8-123.5 billion).

 

This will be around fivefold of what Hadlima made last year (USD 19 million, KRW 24.2 billion).

 

Organon said, “We expect sales of Hadlima to rise gradually with competition among biosimilars to be officially listed by major Pharmacy Benefit Managers (PBMs) in the U.S.

 

From the next year after the biosimilar market is formed in earnest, Hadlima will grow into Organon's second largest grossing product.” The ‘interchangeable biosimilar’ designation sought by Samsung Bioepis was expected to be achieved in Q2 to Q3 of 2024.

 

The interchangeable biosimilar designation is made by the U.S.

 

Food and Drug Administration for biosimilars that are very similar to and have no clinically meaningful differences from the original drug.

 

Drugs that are approved as interchangeable biosimilars may be substituted at the pharmacy without a separate order for switching by the prescribing health care provider.

 

Organon said, “We expect to be able to receive the interchangeable biosimilar designation around one year after Hadlima’s release in July.

 

Our other Humira biosimilar competitors will also be able to receive designation by then.

 

For the first 1-2 years after a drug is launched, whether the drug received the interchangeable biosimilar designation does not become a key point of differentiation for biosimilars during discussions with PBMs.

 

As long as give convince them that we can receive the designation within a reasonable period of time, it will not be a major point for discussion at the negotiation table."