YESINTEK has switching data

Comparative clinical data were evaluated over a 52-week period—including the effects of switching treatment from Stelara® to YESINTEK in a defined population.1

  • YESINTEK was shown to be comparable to Stelara in treating patients with moderate to severe plaque psoriasis at Week 121
  • Clinical efficacy was maintained for patients who continued on YESINTEK as well as for patients who switched from Stelara to YESINTEK after Week 161

Highly similar pharmacokinetics? YES1

STELLAR-1 was a Phase 1, randomized, double-blind, 3-arm, parallel-group study to compare the pharmacokinetic profile of YESINTEK with EU-approved and US-licensed Stelara in 258 healthy adult volunteers.1

  • YESINTEK has a similar pharmacokinetic profile to 
EU-approved and US-licensed ustekinumab reference products1
  • YESINTEK was generally safe and well tolerated by healthy volunteers in this Phase 1 PK study, with no reports of any unexpected AEs1
  • Study drug for each arm was administered subcutaneously1

AE=adverse event; EU=European Union; PK=pharmacokinetic.

MEAN SERUM CONCENTRATION VS TIME PROFILE (PK ANALYSIS SET)

Graphs

AE=adverse event; EU=European Union; PK=pharmacokinetic.

Highly similar efficacy? YES1

STELLAR-2 was a Phase 3, randomized, double-blind, parallel-group, multicenter study to compare the efficacy and safety of YESINTEK and Stelara in patients with moderate to severe chronic plaque psoriasis.1

Patients who completed treatment period 1 with Stelara and achieved PASI 50 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16. Patients who completed treatment period 2 and achieved PASI 75, entered treatment period 3 and continued the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.1

The primary efficacy endpoint was percentage change from baseline in the PASI score at Week 12. Secondary efficacy endpoints included percentage change from baseline in PASI score and raw PASI scores at Weeks 4, 8, 16, 20, 28, 40, and 52.1

STELLAR-2 was a Phase 3, randomized, double-blind, parallel-group, multicenter study to compare the efficacy and safety of YESINTEK and Stelara in patients with moderate to severe chronic plaque psoriasis.1

Patients who completed treatment period 1 with Stelara and achieved PASI 50 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16. Patients who completed treatment period 2 and achieved PASI 75, entered treatment period 3 and continued the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.1

The primary efficacy endpoint was percentage change from baseline in the PASI score at Week 12. Secondary efficacy endpoints included percentage change from baseline in PASI score and raw PASI scores at Weeks 4, 8, 16, 20, 28, 40, and 52.1

EU=European Union; PASI=Psoriasis Area and Severity Index; R=randomization.

  • There was no statistically significant difference in the 
% change from baseline in PASI scores between treatment groups at Week 12 (primary endpoint)1
  • The proportion of patients with PASI 75 and PASI 90 responses through Week 52 were comparable among the treatment groups (secondary endpoints)1
  • Switching from Stelara to YESINTEK had no significant impact on secondary efficacy scores1

*Patients who completed treatment period 1 with Stelara and achieved PASI 50 by Week 12 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16.

†Patients who completed treatment period 2 and achieved at least PASI 75 response at Week 28 entered treatment period 3 to continue the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.

MEAN PERCENTAGE CHANGE IN PASI SCORE  (FULL ANALYSIS SET)

Graphs

PROPORTION OF PATIENTS WITH PASI 75 AND PASI 90

Graphs
*Patients who completed treatment period 1 with Stelara and achieved PASI 50 by Week 12 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16. †Patients who completed treatment period 2 and achieved at least PASI 75 response at Week 28 entered treatment period 3 to continue the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.

STELLAR-2 was a Phase 3, randomized, double-blind, parallel-group, multicenter study to compare the efficacy and safety of YESINTEK and Stelara in patients with moderate to severe chronic plaque psoriasis.1

Patients who completed treatment period 1 with Stelara and achieved PASI 50 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16. Patients who completed treatment period 2 and achieved PASI 75, entered treatment period 3 and continued the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.1

The primary efficacy endpoint was percentage change from baseline in the PASI score at Week 12. Secondary efficacy endpoints included percentage change from baseline in PASI score and raw PASI scores at Weeks 4, 8, 16, 20, 28, 40, and 52.1

Graphical flowchart illustrates the study design

EU=European Union; PASI=Psoriasis Area and Severity Index; R=randomization.

  • There was no statistically significant difference in the 
% change from baseline in PASI scores between treatment groups at Week 12 (primary endpoint)1
  • The proportion of patients with PASI 75 and PASI 90 responses through Week 52 were comparable among the treatment groups (secondary endpoints)1
  • Switching from Stelara to YESINTEK had no significant impact on secondary efficacy scores1

*Patients who completed treatment period 1 with Stelara and achieved PASI 50 by Week 12 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16.

†Patients who completed treatment period 2 and achieved at least PASI 75 response at Week 28 entered treatment period 3 to continue the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.

MEAN PERCENTAGE CHANGE IN PASI SCORE(FULL ANALYSIS SET)

Graphs

PROPORTION OF PATIENTS WITH PASI 75 AND PASI 90

Graphs

*Patients who completed treatment period 1 with Stelara and achieved PASI 50 by Week 12 were rerandomized 1:1 to receive YESINTEK or Stelara at Week 16.

†Patients who completed treatment period 2 and achieved at least PASI 75 response at Week 28 entered treatment period 3 to continue the same treatment until the end of the study (Week 52). For patients who were not eligible to enter treatment period 3, the end of study visit occurred in Week 28.

Highly similar safety profile? YES1

  • YESINTEK has a well-tolerated safety profile, similar to Stelara1
  • Switching from Stelara to YESINTEK caused no clinically meaningful differences in safety events1

TEAEs IN PATIENTS ON SAME TREATMENT THROUGH WEEK 52

Data table comparing Yesintek and Stelara showing clinical safety profiles

TEAEs IN PATIENTS ON SAME TREATMENT THROUGH WEEK 52

Data table comparing Yesintek and Stelara showing clinical safety profiles

Highly similar immunogenicity? YES1

  • The proportion of ADA-positive patients was comparable between the 2 treatment groups at Week 521
  • Switching from Stelara to YESINTEK did not increase immunogenicity1

PROPORTION OF ADA-POSITIVE PATIENTS AT WEEK 52

Graphs

REFERENCES

1. Data on file. Biocon Biologics; 2024. 2. US Food and Drug Administration. Biosimilars: review and approval. Last updated December 13, 2022. Accessed March 11, 2024. https://www.fda.gov/drugs/biosimilars/review-and-approval

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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IMPORTANT SAFETY INFORMATION

Contraindications
YESINTEK is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.
Infections
YESINTEK may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections in patients receiving ustekinumab.
Serious infections requiring hospitalization or otherwise clinically significant infections:

  • 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.

Treatment with YESINTEK should not be initiated in patients with a 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, Salmonella, 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 may be susceptible to these types of infections. Consider diagnostic testing, e.g., tissue culture, stool culture, as dictated by clinical circumstances.
Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with YESINTEK.
Do not administer YESINTEK to patients with active tuberculosis infection. Initiate treatment of latent TB before administering YESINTEK. Closely monitor patients receiving YESINTEK for signs and symptoms of active TB during and after treatment.
Malignancies: YESINTEK is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received ustekinumab in clinical trials.
The safety of ustekinumab has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab who had risk factors for developing non-melanoma skin cancer (NMSC).
All patients receiving YESINTEK, especially those >60 years of age, those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab. 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 post-marketing 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 initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
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 avoid receiving 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. 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.
Allergen Immunotherapy YESINTEK may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Most Common Adverse Reactions

  • Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
  • Crohn’s Disease, induction: vomiting.
  • Crohn’s Disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
  • Ulcerative colitis, induction: nasopharyngitis.
  • Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.

INDICATIONS

YESINTEK (ustekinumab-kfce) 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).

INDICATIONS AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Contraindications
YESINTEK is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.
Infections
YESINTEK may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections in patients receiving ustekinumab.
Serious infections requiring hospitalization or otherwise clinically significant infections:

  • 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.

Treatment with YESINTEK should not be initiated in patients with a 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, Salmonella, 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 may be susceptible to these types of infections. Consider diagnostic testing, e.g., tissue culture, stool culture, as dictated by clinical circumstances.
Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with YESINTEK.
Do not administer YESINTEK to patients with active tuberculosis infection. Initiate treatment of latent TB before administering YESINTEK. Closely monitor patients receiving YESINTEK for signs and symptoms of active TB during and after treatment.
Malignancies: YESINTEK is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received ustekinumab in clinical trials.
The safety of ustekinumab has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab who had risk factors for developing non-melanoma skin cancer (NMSC).
All patients receiving YESINTEK, especially those >60 years of age, those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab. 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 post-marketing 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 initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
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 avoid receiving 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. 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.
Allergen Immunotherapy YESINTEK may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.
Most Common Adverse Reactions

  • Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
  • Crohn’s Disease, induction: vomiting.
  • Crohn’s Disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
  • Ulcerative colitis, induction: nasopharyngitis.
  • Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.

INDICATIONS

YESINTEK (ustekinumab-kfce) 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).

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<Yesintek Copay Assistance Program> Enrollment and Prescription Form

Then fax your completed form to 1-<XXX-XXX-XXXX>.

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You can also e-prescribe your YESINTEK prescription by searching for <NAME TBD> in your EHR.* Be sure to include your patient’s mobile number.†

*<ADDRESS TBD>

†By providing the patient’s phone number, you represent that your patient is aware of the disclosure and has given consent to be contacted 
 regarding this prescription, and by the fulfillment pharmacy.

EHR=electronic health record.

INDICATIONS

YESINTEK (ustekinumab-kfce) 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)