United States: On Monday, 22nd May 2023, Boehringer Ingelheim International GmbH., announced the FDA(Food and Drug Administration)  approval of its autoinjector-Cyltezo Pen. Cyltezo is an interchangeable biosimilar to Humira (adalimumab). (Biosimilars are biologic medication produced by a distinct company from the original inventor, demonstrating no significant variations in safety, potency, and purity.

Cyltezo Pen is a pre-filled, disposable pen device designed to administer adalimumab, a monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), a protein involved in the inflammatory response. It is intended to treat indications including Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis Hidradenitis Suppurativa and Plaque Psoriasis, etc. According to Boehringer Ingelheim, Cyltezo (adalimumab‐adbm) injection, has found subcutaneous application in rheumatoid arthritis for inducing clinical response, reducing signs & symptoms, inhibiting structural damage progression, and improving physical functioning in adult patient with moderate rheumatoid arthritis.

Boehringer Ingelheim will launch this, 40 mg/0.8ml prefilled autoinjector commercially onwards July 1, 2023. 

Cyltezo is made available in a single dose, pre-filled glass syringe and is administered subcutaneously under the guidance of a physician. The special patient-centered design is incorporated with a one-button, three-step activation, a protected needle and equipped with 100% drug visibility. Also, the Cyltezo pen is certified with “Ease of Use” certification from the Arthritis Foundation. The pen's innovative features, such as a dose indicator and audible clicks, enable patients to precisely measure and control their dosage. This ensures consistent and accurate delivery of the medication, reducing the risk of under or overdosing.

According to the Biosimilar Commercial Lead and Executive Director of Boehringer Ingelheim “The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector. We’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”  “We are proud to be the company driving the advancement of biosimilars and delivering the first and only interchangeable biosimilar with Humira,” said Thomas Seck,(Senior vice president of medicine and regulatory affairs at Boehringer Ingelheim). “It is a true milestone and an important step forward for broader adoption in the US and for patient access to affordable medicines.”

According to TechSci Research, the establishment of a patient-centered auto-injection facility will provide the company’s positioning and provide a competitive edge in the Biosimilar market. The introduction of a novel delivery device enhances the company's product portfolio and strengthens its position in the industry.

The launch of the Cyltezo Pen is expected to have a significant impact on the market for autoimmune treatments. Based on the Boehringer Ingelheim’s data-To be the first FDA approved interchangeable Humira biosimilar, Cyltezo on switching several times with reference drug- “AbbVie’s” Humira resulted in no clinical differences for efficacy, pharmacokinetics, immunogenicity, and safety. Thus, it gains eligibility at pharmacy -level substitution across all approved indications providing futuristic patient access to affordable medicines. Also, the Regulatory approval for Cyltezo’s interchangeability was supported by positive data from Boehringer Ingelheim’s Phase III randomized VOLTAIRE-X clinical trial.

Additionally, the Cyltezo Pen's ease of use and patient-friendly design may attract a larger patient population to initiate or continue treatment for their autoimmune conditions. The elimination of vial preparation and simplified administration process may reduce barriers and improve patient adherence to therapy, leading to increased market penetration. This expansion of the patient pool could lead to overall market growth as more people seek treatment for their autoimmune conditions, thereby driving increased demand for adalimumab and similar medications.

The launch of the Cyltezo Pen may induce manufacturers of similar autoimmune treatments to review their pricing strategies to remain competitively active which later potentially impact pricing dynamics. The Cyltezo Pen's approval by the FDA strengthens its case for reimbursement by insurance providers, potentially improving patient access to this treatment option. Ultimately, the launch of the Cyltezo Pen represents a step forward in the pursuit of more effective and patient-friendly autoimmune therapies.