K-pharma speeds up Keytruda biosimilar development...

targeting the market worth KRW 3.3 trillion

Companies commence global phase 3 clinical trials: Samsung Bioepis 'SB27'·Celltrion 'CT-P51'

Competition is expected with the U.S.-based Amgen and Swiss-based Sandoz…Keytruda’s substance patent will expire after 2029

Product photo of Keytruda.

Biopharmaceutical companies in South Korea are fast-developing biosimilars referencing 'Keytruda (pembrolizumab),' which has ranked no.1 in global sales.

 

Samsung Bioepis and Celltrion have initiated global phase 3 trials.

 

Due to Keytruda’s leading position in global sales, competition is expected among the companies mentioned above, as well as U.S.-based Amgen and Swiss Sandoz, to develop biosimilars.

 

Pharmaceutical companies in Korea and overseas are initiating global phase 3 trials for 'Keytruda biosimilar' According to industry sources on June 17th, Celltrion recently submitted an IND to the U.S.

 

Food and Drug Administration (FDA) for its 'CT-P51,' which is being developed as a biosimilar referencing Keytruda.

 

Celltrion will conduct a comparative effectiveness study to demonstrate equivalence between Keytruda, the original pharmaceutical, and CT-P51 in 606 patients with non-small cell lung cancer (NSCLC).

 

Previously, Samsung Bioepis initiated a global Phase 3 trial for Keytruda biosimilar, 'SB27,' in April.

 

Samsung Bioepis plans to conduct a phase 3 trial comparing the effectiveness and safety of SB27 to Keytruda, enrolling 616 patients with metastatic NSCLC across 14 countries.

 

Samsung Bioepis (left), Celltrion.

The analysis shows that competition to develop Keytruda biosimilars among companies, including biopharmaceutical companies in South Korea, globally is on the rise.

 

Currently, U.S.-based Amgen and Swiss-based Sandoz have commenced phase 3 global clinical trials to develop Keytruda biosimilars.

 

Amgen commenced a phase 3 global clinical trial for ABP234 in April of last year, and Sandoz initiated a phase 3 clinical trial for GME751 the same month.

 

Keytruda’s substance patent expires after 2029…biosimilar companies aim for 'agreement' with the original company Global companies are expected to complete their biosimilar development between 2025 and 2026.

 

Keytruda’s substance patent will expire in November 2029 in the United States and in January 2031 in Europe.

 

Other patents, such as the use patent, formulation patent, therapeutic method-related patent, and process-related patent, tied to indications are still valid.

 

Since Keytruda has over 30 approved indications, more than tens of patents are tied to these.

 

The original company, with an 'evergreening' strategy, has secured the patent validity of Keytruda until after 2040 through numerous patents.

 

Since there are more than tens of patents to overcome, companies developing biosimilars aim to reach an 'agreement' with the original company rather than launching products after patent challenges.

 

Previously, in the cases of global pharmaceuticals, such as Humira and Enbrel, companies developing biosimilars launched their products through agreements with the original company, either by paying royalties or adjusting release dates.

 

For these reasons, pharmaceutical industry experts anticipate that the timing of completing clinical trials will be a crucial variable for biosimilar developers.

 

Completing biosimilar development quickly can provide an advantageous position over competing firms in negotiations over royalty payments to original companies or adjustments to launch dates.

 

Top 10 pharmaceuticals in global sales prospects for 2024 (source: Evaluate)

According to the pharmaceutical market research firm Evaluate, Keytruda generated US$25 billion (approximately KRW 33 trillion) in global sales last year, becoming the top-selling pharmaceutical globally.

 

Previously, the top-selling pharmaceuticals were Humira from AbbVie from 2019 to 2020, and Pfizer's COVID-19 vaccine Comirnaty from 2021 to 2022.

 

Keytruda is rapidly expanding sales through actively adding indications.

 

After reaching US$10 billion (approximately KRW 13.3 trillion) in 2019, it showed steady growth topping US$20 billion (approximately KRW 26.7 trillion) in 2022.

 

To date, Keytruda has secured more than 40 indications.

 

In the Korean market, Keytruda is also a leading pharmaceutical with the highest sales.

 

According to the pharmaceutical market research firm IQVIA, Keytruda generated sales of KRW 398.7 billion last year, up 66% from KRW 239.6 billion in 2022.