FDA Approves Another Interchangeable Biosimilar | McDonnell Boehnen Hulbert & Berghoff LLP
Earlier this year, the U.S. Food and Drug Administration announced approval of Amgen’s Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech’s Stelara (ustekinumab). The drug was approved for multiple inflammatory disorders:
Adult patients with:
• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.
Pediatric patients 6 years of age and older with:
• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
• active psoriatic arthritis.
Wezlana shares with Stelara a risk of increased infection, and has as side effects “nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.” The biosmilar showed “no clinically meaningful differences from” Stelara and satisfied the requirements for interchangeable status under § 351(k)(2)(B) of the Public Health Service Act (codified in 42 U.S.C. § 262(k)(2)(B)).
This approval brings to 45 the number of approved biosimilar products of which five are interchangeable.
* Approved as interchangeable biosimilar
