Boehringer Ingelheim broadens access to Humira® biosimilar adalimumab-adbm

Boehringer Ingelheim has entered into an agreement with Quallent Pharmaceuticals to enhance patient access to a biosimilar medication, adalimumab-adbm, in the U.S. This collaboration underscores Boehringer Ingelheim's commitment to providing affordable biologic medicines. Quallent Pharmaceuticals, a private label pharmaceutical distributor, will work with Boehringer Ingelheim to make citrate-free adalimumab-adbm more widely available to patients suffering from chronic inflammatory diseases.

Chris Marsh, Senior Vice President of Value and Access at Boehringer Ingelheim, highlighted the significance of this partnership, stating that biosimilars like adalimumab-adbm can benefit more patients by providing cost-effective biologic treatment options and reducing expenses for the U.S. healthcare system. He emphasized Boehringer Ingelheim's dedication to promoting the biosimilar market and expanding access to these medications.

Under the terms of the agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent Pharmaceuticals. Boehringer Ingelheim will continue to market its own branded version of adalimumab-adbm, known as Cyltezo®. John Caulfield, President of Quallent Pharmaceuticals Health, expressed enthusiasm for the partnership, noting that it aligns with Quallent's mission to provide safe and affordable medications to patients. The company plans to introduce a copay assistance program to further facilitate patient access to adalimumab-adbm.

Quallent Pharmaceuticals will offer both high and low-concentration citrate-free formulations of adalimumab-adbm, available as pre-filled syringes or pens. The interchangeability designation for the low-concentration formulation will extend to Quallent's private-labeled version, ensuring equivalency in treatment.

Biosimilars are biologic medicines developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in safety, potency, and purity. An interchangeable biosimilar, as designated by the FDA, can be auto-substituted for the reference product by pharmacists, following state laws that govern notification procedures for providers and patients. To achieve this designation, biosimilars must meet stringent FDA standards and undergo additional testing, including studies that demonstrate no increased risk when switching from the reference product.

Boehringer Ingelheim is a leading producer of biologic medicines, supporting a diverse pipeline and offering contract manufacturing services for other companies' biopharmaceuticals. The company's Biopharmaceutical Contract Manufacturing business has helped bring numerous biologics to the market, addressing therapeutic needs in oncology, immunology, and cardiovascular conditions.

Adalimumab-adbm, branded as Cyltezo®, is a TNF blocker used to treat various chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, plaque psoriasis, and non-infectious uveitis. It is vital for patients and healthcare providers to be aware of the potential risks associated with adalimumab-adbm, including serious infections, cancer risks, and other side effects.

Patients should discuss their medical history and current health conditions with their healthcare provider before starting treatment with adalimumab-adbm. It is also essential to monitor for any adverse reactions or infections during treatment and report them to a healthcare professional immediately.

In summary, the collaboration between Boehringer Ingelheim and Quallent Pharmaceuticals aims to make adalimumab-adbm more accessible, improve patient outcomes, and reduce healthcare costs by leveraging the benefits of biosimilar medications.