From the First to the Best

The U.S. Food & Drug Administration (FDA) approved the first monoclonal antibody (mAb) biosimilar medication in 2016, and today, the number of biosimilars cleared for the American market has reached 40, with many more in the pipeline. Remarkably, however, biosimilar market share in the United States is still low – particularly for immunology drugs, which were among the first biosimilars to be approved. Yet the best-selling biopharmaceutical in the U.S., adalimumab (Humira), is facing biosimilar competition this year, and product characteristics and reimbursement decisions are likely to impact biosimilar uptake.

Momentum for biosimilars in the U.S. is building. McKinsey & Co. predicts that the U.S. market for biosimilars will grow at a compound annual rate of 26% between 2020 and 2025. Depending on how strong the pickup of new biosimilars is, they could generate somewhere between $38.4 billion to $124.5 billion in savings to the U.S. health care system, RAND Corporation estimates. While biosimilars are now widely known for their high quality and affordability, Celltrion is committed to delivering more than a stable supply of lower- cost biologics.

Moreover, Celltrion is driving patient-centric innovation and has earned the loyalty of patients, physicians and health systems worldwide. Its industry-leading products include the world's first biosimilar monoclonal antibody, Inflectra (infliximab), which was developed by Celltrion and distributed by Pfizer in the U.S. Inflectra treats immune-mediated inflammatory diseases (IMIDs) and has grown its market share in the U.S. from 6% in 2018 to 33% now, second only to branded Remicade. Not settling on its biosimilar growth, Celltrion will strive to achieve patient-centric treatment and broaden treatment choices for patients through value-added medicines and biosimilars.

Improving quality of care and patient outcomes

Celltrion is gearing up to introduce more value-added medicines to the U.S. market. Celltrion's innovative infliximab, CT-P13 SC, is expected to receive FDA approval as a new drug in late 2023. Celltrion has submitted the global Phase III pivotal data to support its submission package to the FDA to enable this innovative and convenient treatment to become available for U.S. patients. It will be the first and only subcutaneous version of infliximab, promising not only clinical benefits but also greater convenience for patients. This patient-centric treatment can be administered at home rather than requiring travel to a medical office to receive the drug. CT-P13 SC has already been approved in Europe in 2020 and is showing improved effectiveness, along with rapid uptake in the market.

With the rapid aging of the population, many of the therapeutic areas Celltrion targets are growing quickly. For example, an estimated 1.6 million Americans have IBD, an increase of 200,000 patients since 2011, according to the Crohn’s and Colitis Foundation. IBDs such as Crohn's disease and ulcerative colitis are chronic diseases with limited treatment options. This innovative infliximab will provide patients more freedom in their treatment choices.

Another area of innovation that Celltrion has prioritized is developing biosimilar formulations that respond to market demands. We are careful to match the strengths and presentations of the originator drugs. At the same time, we develop formulations aimed at personalizing treatments to patients’ needs. Value-added features such as a high- concentration, low-volume doses reduce injection discomfort. Formulations that are citrate- and latex-free lower the risk of injection pain and allergic reactions.

Expanding to support growing demand

As global demand for biologics grows, control over supply chain has been a key component to ensure stable supply of pharmaceuticals. In response to these tumultuous times globally, Celltrion has been committed to building up a strong manufacturing and distribution infrastructure to meet expected demand. Celltrion is investing to secure additional capacity and will look into building a U.S. facility in line with the White House’s recent executive order to bolster U.S. based biomanufacturing. Building on the extended supply, Celltrion anticipates to achieve a stable and sustainable supply chain.

As we expand, Celltrion’s strategy will be to continue to provide innovative drugs that match or exceed the attributes of the original medicine. Alongside the development of new drugs, we anticipate launching at least one biosimilar product every year, reaching a total of 18 products by 2030.

In bringing our innovations to the U.S. market, we are proud to contribute to patients in diverse disease areas, add value to the U.S. health system and improve quality of care.