US FDA Approves Celltrion’s AVTOZMA (Tocilizumab-ctzd) and ACKEMRA Biosimilars
In a significant milestone for the global healthcare industry, the US Food and Drug Administration (FDA) has approved two biosimilars from Celltrion, a leading biotechnology company in South Korea. The two products, AVTOZMA (Tocilizumab-ctzd) and ACKEMRA, are the company’s latest additions to its growing portfolio of biosimilars.
AVTOZMA is a biosimilar of Roche’s Actemra (tocilizumab), an injectable biologic medication used to treat moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, and adult and pediatric patients with active polyarticular idiopathic arthritis. Tocilizumab is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptors, reducing the production of pro-inflammatory compounds that can contribute to the progression of these diseases.
ACKEMRA, on the other hand, is a biosimilar of Roche’s Kevzara (sarilumab), a monoclonal antibody developed to treat moderate to severe rheumatoid arthritis. Kevzara is also a humanized monoclonal antibody that targets the IL-6 receptor, providing relief from the signs and symptoms of this chronic condition.
The FDA’s approval of AVTOZMA and ACKEMRA is seen as a major breakthrough in the field of biosimilars, offering patients and healthcare systems an affordable alternative to expensive branded biologics. According to the National Health Care Anti-Trafficking Alliance (NHCAA), the average price of branded biological therapies, like Actemra and Kevzara, can range from $1,000 to $3,000 per week, or up to $52,000 per year. In contrast, the cost of biosimilars like AVTOZMA and ACKEMRA is expected to be significantly lower, with some studies suggesting a reduction of up to 80% in treatment costs.
"Today’s approval is a testament to Celltrion’s commitment to providing patients with access to high-quality, affordable medicines," said Dr. Sang-jin Pak, the company’s CEO. "We are proud to be at the forefront of the biosimilar revolution, working tirelessly to bring innovative, clinically equivalent, and cost-effective alternatives to market. With AVTOZMA and ACKEMRA, we are one step closer to making health care more accessible and sustainable for those in need."
In assessing the bioequivalence of AVTOZMA and ACKEMRA, the FDA conducted a comprehensive review of the products, including a comprehensive evaluation of the data submitted by Celltrion. The agency’s approval of both products comes after a thorough analysis of the results from two pivotal studies, which demonstrated that the biosimilars are interchangeable with their reference products, Actemra and Kevzara, in terms of safety, efficacy, and quality.
The approval of AVTOZMA and ACKEMRA marks a significant milestone in the company’s history, with Celltrion solidifying its position as a leader in the global biosimilar market. As the demand for affordable, high-quality biosimilars continues to grow, this development will pave the way for even more innovative treatments to reach the market, further improving patient outcomes and stimulating global healthcare progress.
