Antirheumatic Biosimilar Gets FDA Nod

Article

Boehringer said they also plan to seek approval for an auto-injector of the biosimilar to expand options for patients.

Boehringer Ingelheim Pharmaceuticals announced that the FDA has approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab), according to a press release.

Cyltezo was approved as a monotherapy or in combination with methotrexate or a non-biologic disease-modifying anti-rheumatic drug. It is administered through a pre-filled syringe.

Boehringer said they also plan to seek approval for an auto-injector of the biosimilar to expand options for patients.

“Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, senior vice president and head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the US, and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

Cyltezo was approved to treat:

· moderate to severe active rheumatoid arthritis

· moderate to severe polyarticular juvenile idiopathic arthritis

· active psoriatic arthritis

· active ankylosing spondylitis (an arthritis that affects the spine)

· moderate to severe active adult Crohn’s disease

· moderate to severe active ulcerative colitis

· moderate to severe plaque psoriasis

The biosimilar approval was based on numerous findings from analytical, pharmacological, non-clinical and clinical development trials that showed Cyltezo is highly-similar to the reference product.

Boehringer expects that the European Medicines Agency will provide a regulatory decision for Cyzelto this year.

Due to patent litigation with AbbVie, Cyltezo is not currently commercially available, according to the release. Amgen’s Humira biosimilar, Amjevita (adalimumab-atto), is engaged in a similar lawsuit. AbbVie alleges that Amgen is infringing on 61 Humira patents, but are only including 10 in the lawsuit. Despite Amjevita’s approval in September 2016, the drug has yet to be launched in the US market.

This article originally appeared on Specialty Pharmacy Times.

Related Videos
Female Pharmacist Holding Tablet PC - Image credit: Tyler Olson | stock.adobe.com
African American male pharmacist using digital tablet during inventory in pharmacy - Image credit: sofiko14 | stock.adobe.com
Young woman using smart phone,Social media concept. - Image credit: Urupong | stock.adobe.com
selling mental health medication to man at pharmacy | Image Credit: Syda Productions - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg - stock.adobe.com
Image credit: rawpixel.com | stock.adobe.com
Medical team -- Image credit: Flamingo Images | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.