Samsung Bioepis Co. and Celltrion Inc. are outpacing long-established global drug manufacturers such as Amgen Inc. and Sandoz in the antibody biosimilar market with their robust R&D capabilities and fast-tracked clinical trial process.
The two South Korean companies have completed Phase 3 trials more than a year ahead of their US and European competitors for some drugs. Phase 3 clinical trials are conducted to demonstrate a drug’s efficiency and safety, requiring significantly more time and investment than Phase 1.
Samsung and Celltrion have secured the highest number of approved antibody biosimilars in the US and Europe, which accounted for 80% of the world biosimilar market.
On Monday, Celltrion said its biosimilar to Xolair, a treatment for allergic asthma and chronic spontaneous urticaria, has got the nod from the US Food and Drug Administration (FDA).
The approval brought the number of its FDA-approved antibody biosimilars to 10, matching that of Samsung Bioepis. This placed both companies at the top of the US antibody biosimilar market in the number of approved products.
With this, Celltrion has displaced US-based Amgen, which held the top position alongside Samsung Bioepis in the US last year. Amgen has secured approval for eight antibody biosimilars in its home country, followed by Sandoz with seven.
In Europe, Samsung and Celltrion have won approval for 11 antibody biosimilar products, respectively. That marked the highest number for antibody biosimilars granted to any company in the continent.
Switzerland-based Sandoz follows with eight approvals, while Amgen has received approval for five.
According to ClinicalTrials, which tracks global clinical studies, South Korean biosimilar manufacturers have been as much as one year faster than their global peers in completing Phase 3 clinical trials for treatments targeting autoimmune and rare diseases.
As an example, in the development of biosimilars referencing Humira, an autoimmune disease treatment, Celltrion and Samsung completed its Phase 3 trials in just 17 months. By comparison, Sandoz took 26 months to complete the same phase, according to the US data company.
For biosimilars referencing Stelara, Johnson & Johnson’s blockbuster drug for autoimmune disorders, Celltrion and Samsung completed Phase 3 tests in 16 and 17 months, respectively, compared to Amgen’s 19-month timeline.
Samsung Bioepis also demonstrated speed in developing biosimilars for Soliris, a treatment for blood disorders, completing Phase 3 tests in 27 months. That is even faster than Amgen’s 42 months.
For a generic drug of Herceptin, a monoclonal antibody therapy, Samsung completed Phase 3 trials in 35 months, ahead of Amgen’s 40 months and Celltrion’s 53 months.
Last year, Samsung Bioepis proved its efficiency in regulatory processes when it submitted all requested additional data, which involves 100 to 200 queries, to the FDA and the European Medicines Agency within a month. The review process typically takes over three months to complete.
By Dae-Kyu Ahn
powerzanic@hankyung.com
Yeonhee Kim edited this article.
