FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

Title: FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation for Improved Treatment of Inflammatory Diseases


Sandoz, a pharmaceutical company that specializes in developing generic and biosimilar drugs, has received approval from the United States Food and Drug Administration (FDA) for a new citrate-free formulation of the drug Adalimumab. This new formulation aims to address the limitations of the current citrate-based formulation and improve treatment outcomes for patients with inflammatory diseases. In this blog post, we will explore the key points surrounding Sandoz’s citrate-free Adalimubab formulation and its potential impact on inflammatory disease treatment.

Key Points:

  1. Understanding Inflammatory Diseases:

Inflammatory diseases are conditions that cause inflammation in various parts of the body. They can affect any organ, tissue, or system, causing symptoms such as pain, swelling, redness, and impaired function. Examples of inflammatory diseases include rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.

  1. Adalimumab:

Adalimumab is a biologic drug used to treat inflammatory diseases. It works by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), which is involved in the inflammatory process. Adalimubab is designed to reduce inflammation and alleviate symptoms associated with inflammatory diseases.

  1. Citrate-Free Formulation:

The current Adalimubab formulation contains citrate, a substance that may cause discomfort during injection and may affect the drug’s efficacy. The new citrate-free formulation eliminates these limitations and has been designed to improve patient experience and treatment outcomes.

  1. Clinical Trials:

Clinical trials of the citrate-free Adalimubab formulation found that it was well-tolerated, with comparable safety and efficacy to the current formulation. The study participants reported less injection site pain and improved satisfaction with their treatment experience.

  1. Potential Benefits:

The citrate-free Adalimubab formulation offers several potential benefits for patients with inflammatory diseases. Its improved injection experience may lead to better adherence to treatment, which can lead to better disease control and improved outcomes overall. Additionally, the elimination of citrate may improve the drug’s efficacy and reduce adverse effects.

  1. Ongoing Research:

While the approval of the citrate-free Adalimubab formulation is a step forward in the treatment of inflammatory diseases, there is still much to learn and explore as researchers continue to refine and improve treatment options. Ongoing research will help to further understand the mechanisms of inflammatory disease and identify new therapeutic strategies to improve patient outcomes.


Sandoz’s new citrate-free Adalimubab formulation represents a significant development in the treatment of inflammatory diseases. The elimination of citrate provides potential benefits for patients, including improved injection comfort, reduced adverse effects, and better efficacy. As researchers continue to explore new therapeutic strategies and technologies, we can expect to see further advancements in the treatment of inflammatory diseases. With continued investment and collaboration, we can hope to significantly improve outcomes for patients with these complex and debilitating conditions.