Drug/Device Pipeline

FDA Approves Humira Biosimilar Cyltezo

The FDA has approved the second biosimilar to Humira, Cyltezo, for several gastroenterological, rheumatological and dermatological indications.

Cyltezo (adalimumab-adbm, Boehringer Ingelheim), a biosimilar to Humira (adalimumab, AbbVie), is an anti-TNF drug delivered by subcutaneous injection for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe Crohn’s disease, moderate to severe ulcerative colitis, and moderate to severe chronic plaque psoriasis in adults, and moderate to severe polyarticular juvenile idiopathic arthritis in children aged 4 years and older.

“It is not known if Cyltezo is effective in people who stopped responding to or could not tolerate TNF-blocker medicines,” according to the FDA medication guide.

The prescribing information includes warnings about serious infections and malignancy risks, including lymphoma, associated with the drug. The most common adverse reactions included infections, injection site reactions, headache and rash.

This is the second biosimilar to Humira approved by the FDA, the first being Amjevita (adalimumab-atto, Amgen), approved in September 2016. Another Humira biosimilar, Imraldi (Samsung Bioepis) was approved by the European Commission last week.

 “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,” Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at Boehringer Ingelheim, said in a press release. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

The approval is based on analytical, pharmacological, non-clinical and clinical development studies showing Cyltezo is biosimilar to Humira. It is not yet commercially available and the company is engaged in patent litigation with AbbVie, according to the press release.

The company added that it will also seek approval for an auto-injector of Cyltezo, and expects the European Medicines Agency to issue an opinion on the marketing authorization application this year.

Biosimilars are biologics determined to be “highly similar” to a previously approved biologic medication, having “no clinically meaningful differences in terms of safety and effectiveness,” according to the FDA. For more information on biosimilars, visit our Biosimilar Resource Center. – by Adam Leitenberger

Reference:

FDA. Highlights of [Cyltezo] prescribing information. Accessed August 28, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf

Disclosure: Blanarik is employed by Boehringer Ingelheim.

Editor's note: This article was updated on August 30 with additional information from the manufacturer.

The FDA has approved the second biosimilar to Humira, Cyltezo, for several gastroenterological, rheumatological and dermatological indications.

Cyltezo (adalimumab-adbm, Boehringer Ingelheim), a biosimilar to Humira (adalimumab, AbbVie), is an anti-TNF drug delivered by subcutaneous injection for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe Crohn’s disease, moderate to severe ulcerative colitis, and moderate to severe chronic plaque psoriasis in adults, and moderate to severe polyarticular juvenile idiopathic arthritis in children aged 4 years and older.

“It is not known if Cyltezo is effective in people who stopped responding to or could not tolerate TNF-blocker medicines,” according to the FDA medication guide.

The prescribing information includes warnings about serious infections and malignancy risks, including lymphoma, associated with the drug. The most common adverse reactions included infections, injection site reactions, headache and rash.

This is the second biosimilar to Humira approved by the FDA, the first being Amjevita (adalimumab-atto, Amgen), approved in September 2016. Another Humira biosimilar, Imraldi (Samsung Bioepis) was approved by the European Commission last week.

 “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,” Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at Boehringer Ingelheim, said in a press release. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

The approval is based on analytical, pharmacological, non-clinical and clinical development studies showing Cyltezo is biosimilar to Humira. It is not yet commercially available and the company is engaged in patent litigation with AbbVie, according to the press release.

The company added that it will also seek approval for an auto-injector of Cyltezo, and expects the European Medicines Agency to issue an opinion on the marketing authorization application this year.

Biosimilars are biologics determined to be “highly similar” to a previously approved biologic medication, having “no clinically meaningful differences in terms of safety and effectiveness,” according to the FDA. For more information on biosimilars, visit our Biosimilar Resource Center. – by Adam Leitenberger

Reference:

FDA. Highlights of [Cyltezo] prescribing information. Accessed August 28, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf

Disclosure: Blanarik is employed by Boehringer Ingelheim.

Editor's note: This article was updated on August 30 with additional information from the manufacturer.

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