FDA Approval for Generic to Votrient
October 19, 2023 – Apotex Corp.; Sun Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA, Inc., have been approved by the FDA for the use of Pazopanib Hydrochloride Tablets (200 mg/base) for treatment of Renal Cell Carcinoma; Soft Tissue Sarcoma. This approval is as a generic to Votrient.
FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara
October 31, 2023 — The U.S. Food and Drug Administration has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:
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.
The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.
Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are 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.
