FDA Approves Yesintek
FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara
Bengaluru, Karnataka, India, December 01, 2024 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the U.S. Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab).
Yesintek, a monoclonal antibody, is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
Biocon Biologics Ltd had previously notified the Stock Exchange on Feb 29, 2024, that the Company had entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Yesintek in the United States of America no later than on February 22, 2025, upon approval from the U.S. FDA.
Source: Biocon Biologics Ltd.
Yesintek Indications and Important Safety Information
INDICATIONS
Yesintek is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
- moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
- moderately to severely active Crohn’s disease (CD).
- moderately to severely active ulcerative colitis.
Pediatric patients 6 years and older with:
- moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
- active psoriatic arthritis (PsA).
IMPORTANT SAFETY INFORMATION
Infections
- Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.
- Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:
- Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections.
- Psoriatic arthritis: cholecystitis.
- Crohn's disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
- Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
- Avoid initiating treatment with Yesintek in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Yesintek in patients with a chronic infection or a history of recurrent infection.
- Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Yesintek and discontinue Yesintek for serious or clinically significant infections until the infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular Infections
- Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.
- It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances).
Pre-treatment Evaluation for Tuberculosis
- Evaluate patients for tuberculosis infection prior to initiating treatment with Yesintek .
- Avoid administering Yesintek to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering Yesintek . Consider anti-tuberculosis therapy prior to initiation of Yesintek in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Yesintek for signs and symptoms of active tuberculosis during and after treatment.
Malignancies
- Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.
- The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
- There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving Yesintek for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment.
Hypersensitivity Reactions
- Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Yesintek .
Posterior Reversible Encephalopathy Syndrome (PRES)
- Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.
- Monitor all patients treated with Yesintek for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Yesintek.
Immunizations
- Prior to initiating therapy with Yesintek , patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Yesintek should not receive live vaccines. Avoid administering BCG vaccines during treatment with Yesintek or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Yesintek because of the potential risk for shedding from the household contact and transmission to patient.
- Non-live vaccinations received during a course of Yesintek may not elicit an immune response sufficient to prevent disease.
Noninfectious Pneumonia
- Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue Yesintek and institute appropriate treatment
Most Common Adverse Reactions
The most common adverse reactions associated with ustekinumab products are:
- Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
- Crohn's Disease, induction (≥3%): vomiting.
- Crohn's Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
- Ulcerative colitis, induction (≥3%): nasopharyngitis.
- Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.
Reference: Yesintek (ustekinumab-kfce) Prescribing Information. Biocon Biologics Ltd.; December 2024.
Posted: December 2024
Yesintek (ustekinumab-kfce) FDA Approval History
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