Celltrion

Given its capital- and technology-intensive nature, the global biopharmaceutical industry has long been an exclusive prerogative of a select few multinational pharmaceutical companies. Patients who can not afford the rising costs of biopharmaceuticals are often denied access to treatment.

Propelled by the desire to provide patients with more affordable and effective treatments,
We began our biosimilar development journey. Our mission was to establish a company capable of leading the global biopharmaceutical market.

In 2007, Celltrion began to develop the world’s first antibody biosimilar named Remsima. Antibody biosimilars are notoriously difficult to develop compared to first-generation biopharmaceuticals, which mostly consist of protein drugs.

Our efforts finally came to fruition in December 2009. With the approval of its clinical trial plans from drug safety authorities across various countries, the company launched large-scale clinical trials in 19 different countries for two years, with a total of 856 patients.

After clinical trials, newly developed drugs go through a rigorous review by advisory commissions consisting of medical experts to obtain approval from authorities like the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Celltrion proved the efficacy and safety of Remsima through the successful conclusion of clinical trials and secured EMA’s approval for the distribution of the drug in 2013 and the FDA’s approval in 2016.
Remsima has been approved in more than 80 countries worldwide. With a 60% market share in Europe, it has secured its place as a leading antibody biosimilar.

Remsima is the first antibody biosimilar to reach the American market, which makes up half of the entire global biopharmaceutical market.
Inspired by Remsima’s success, Celltrion is now preparing to launch other innovative drugs, including Herzuma and Truxima, which are oncological biosimilars, and Temixys, a small molecule pharmaceutical for HIV treatment.
Celltrion will continue to blaze new trails and discover new opportunities.