STAY FOCUSED

ON TREATING HER2+ CANCER

Biocon Biologics is committed to being your long-term biosimilars partner.
So you can remain committed to what matters most.

OGIVRI is highly similar to Herceptin^®, and is backed by an oncology biosimilars company you can trust.^2-5

SUPPORT

FOR YOU AND YOUR PATIENTS

From the moment you prescribe OGIVRI, Biocon Biologics provides you with the resources and support you need to help your patients get started on their therapy.

Copay Assistance

Access to OGIVRI for commercially insured patients with a copay as low as $0.*

See full terms and conditions.

Coding and Billing

Information regarding applicable coding for OGIVRI and its administration (OGIVRI has been assigned a product billing code of Q5114).

Download the Coding and Billing Guide.

BenefitS Investigation

Information on patient-specific insurance coverage requirements and patient cost-sharing aspects such as copay, coinsurance, and out-of-pocket maximum.

Prior Authorization/ Reauthorization Assistance

Requirement and submission details assistance, status tracking, and help with payer-specific forms.

Coverage/Claim Appeal
Assistance

Appeal requirement verification and appeal  status/resolution tracking.

Insurance AND Alternate Coverage

Patient insurance plan enrollment verification and identification of state programs, third-party charitable foundations, or other coverage options.

Patient Assistance

Medication that may be available free of charge to patients without insurance coverage for OGIVRI who cannot afford their medication.^†

PATIENT BROCHURE

An informative guide for patients new to OGIVRI.

Download the Patient Brochure.

*Eligibility requirements apply.

^†Eligibility requirements apply based on residency, income, and other factors. Contact My Biocon Biologics^TM for more information.

Copay Assistance

Access to OGIVRI for commercially insured patients with a copay as low as $0.*

See full terms and conditions.

BenefitS Investigation

Information on patient-specific insurance coverage requirements and patient cost-sharing aspects such as copay, coinsurance, and out-of-pocket maximum.

Coverage/Claim Appeal
Assistance

Appeal requirement verification and appeal  status/resolution tracking.

Patient Assistance

Medication that may be available free of charge to patients without insurance coverage for OGIVRI who cannot afford their medication.^†

Coding and Billing

Information regarding applicable coding for OGIVRI and its administration (OGIVRI has been assigned a product billing code of Q5114).

Download the Coding and Billing Guide.

Prior Authorization/ Reauthorization Assistance

Requirement and submission details assistance, status tracking, and help with payer-specific forms.

Insurance AND Alternate Coverage

Patient insurance plan enrollment verification and identification of state programs, third-party charitable foundations, or other coverage options.

PATIENT BROCHURE

An informative guide for patients new to OGIVRI.

Download the Patient Brochure.

*Eligibility requirements apply.

^†Eligibility requirements apply based on residency, income, and other factors. Contact My Biocon Biologics^TM for more information.

MY BIOCON BIOLOGICS^TM SPECIALISTS ARE HERE TO HELP

The My Biocon Biologics Patient Support Program offers assistance to individuals prescribed OGIVRI.

Our specialists can provide support for everything from coverage and claim concerns to copay and financial assistance questions*

Help is available Monday-Friday 9 AM-8 PM ET—just call 1-833-695-2623

Enroll your patients through the My Biocon Biologics portal*

Download the

Download the My Biocon Biologics enrollment form.

*Eligibility requirements apply.

MY BIOCON BIOLOGICS^TM
SPECIALISTS ARE HERE TO HELP

The My Biocon Biologics Patient Support Program offers assistance
to individuals prescribed OGIVRI.

Our specialists can provide support for everything from coverage and claim concerns to copay and financial assistance questions*

Help is available Monday-Friday
9 AM-8 PM ET—just call
1-833-695-2623

Enroll your patients through the My Biocon Biologics portal*

Download the My Biocon Biologics enrollment form.

*Eligibility requirements apply.

BIOSIMILARITY

YOU CAN COUNT ON

Totality of evidence for OGIVRI is based on similarity in analytical, clinical, and extrapolation data to Herceptin.²

DEMONSTRATED EQUIVALENCE when compared to Herceptin in efficacy and safety in the Phase 3 HERITAGE trial of patients with HER2+ metastatic breast cancer.^3,4

SIMILAR SAFETY with no new safety signals observed in long-term follow-up and no significant difference in LVEF between OGIVRI and Herceptin.^3,4

LVEF=left ventricular ejection fraction.

OGIVRI IS AVAILABLE In Single-DOSE and Multi-dose Vials

Multiple dosage forms help reduce waste and let you choose the right dosage form for your practice.²

150 mg single-dose vial

NDC: 83257-001-11

420 mg multi-dose vial

NDC: 83257-004-12

OGIVRI has been assigned the product-specific billing code Q5114
Available in full-line and specialty channels
Store OGIVRI vials in the refrigerator at 35 to 46 °F (2 to 8 °C)

Please see Full Prescribing Information for the dosing of OGIVRI.

A FLEXIBLE ONCOLOGY

PARTNER

Biocon Biologics provides more than just biosimilars—let us flex our capabilities to meet your unique oncology needs.

With a portfolio of oncology biosimilars on the market and in our pipeline, we are committed to the long-term sustainability of biosimilars technology.

REFERENCES

1. FDA approves first biosimilar for the treatment of certain breast and stomach cancers. FDA News Release. December 1, 2017. Last reviewed January 16, 2018. Accessed August 13, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-certain-breast-and-stomach-cancers 2. OGIVRI. Prescribing information. Biocon Biologics Inc; 2024. 3. Rugo HS, Pennella EJ, Gopalakrishnan U, et al. Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer. Breast Cancer Res Treat. 2021;188(2):369-377. 4. Rugo HS, Barve A, Waller CF, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA. 2017;317(1):37-47. 5. 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

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Cardiomyopathy

OGIVRI administration can result in sub-clinical and clinical cardiac failure. The incidence and severity are highest in patients receiving OGIVRI with anthracycline-containing chemotherapy regimens
OGIVRI can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. OGIVRI can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
Evaluate left ventricular function in all patients prior to and during treatment with OGIVRI
Discontinue OGIVRI treatment in patients receiving adjuvant therapy and withhold OGIVRI in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions

OGIVRI administration can result in serious and fatal infusion reactions
Symptoms usually occur during or within 24 hours of OGIVRI administration
Interrupt OGIVRI infusion for dyspnea or clinically significant hypotension
Monitor patients until symptoms completely resolve
Discontinue OGIVRI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia

Embryo-Fetal Toxicity

Exposure to OGIVRI during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Verify the pregnancy status of females of reproductive potential prior to the initiation of OGIVRI
Advise pregnant women and females of reproductive potential that exposure to OGIVRI during pregnancy or within 7 months prior to conception can result in fetal harm
Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of OGIVRI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for OGIVRI treatment and any potential adverse effects on the breastfed child from OGIVRI or from the underlying maternal condition

Pulmonary Toxicity

OGIVRI administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
Discontinue OGIVRI in patients experiencing pulmonary toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

Adjuvant Breast Cancer: Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
Metastatic Breast Cancer: Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
Metastatic Gastric Cancer: Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

INDICATIONS

Adjuvant Breast Cancer

OGIVRI is indicated in adults for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen consisting of doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
As part of a treatment regimen with docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

*High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3

Metastatic Breast Cancer

OGIVRI is indicated in adults:

In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Gastric Cancer

OGIVRI is indicated in adults, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

You may report side effects to the 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including BOXED WARNING.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY

Cardiomyopathy

Infusion Reactions; Pulmonary Toxicity

Embryo-Fetal Toxicity

Cardiomyopathy

OGIVRI administration can result in sub-clinical and clinical cardiac failure. The incidence and severity are highest in patients receiving OGIVRI with anthracycline-containing chemotherapy regimens
OGIVRI can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. OGIVRI can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
Evaluate left ventricular function in all patients prior to and during treatment with OGIVRI
Discontinue OGIVRI treatment in patients receiving adjuvant therapy and withhold OGIVRI in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions

OGIVRI administration can result in serious and fatal infusion reactions
Symptoms usually occur during or within 24 hours of OGIVRI administration
Interrupt OGIVRI infusion for dyspnea or clinically significant hypotension
Monitor patients until symptoms completely resolve
Discontinue OGIVRI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia

Embryo-Fetal Toxicity

Exposure to OGIVRI during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Verify the pregnancy status of females of reproductive potential prior to the initiation of OGIVRI
Advise pregnant women and females of reproductive potential that exposure to OGIVRI during pregnancy or within 7 months prior to conception can result in fetal harm
Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of OGIVRI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for OGIVRI treatment and any potential adverse effects on the breastfed child from OGIVRI or from the underlying maternal condition

Pulmonary Toxicity

OGIVRI administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
Discontinue OGIVRI in patients experiencing pulmonary toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions

Adjuvant Breast Cancer: Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
Metastatic Breast Cancer: Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
Metastatic Gastric Cancer: Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

INDICATIONS

Adjuvant Breast Cancer

OGIVRI is indicated in adults for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen consisting of doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
As part of a treatment regimen with docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

*High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3

Metastatic Breast Cancer

OGIVRI is indicated in adults:

In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Gastric Cancer

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including BOXED WARNING.

STAY FOCUSED

ON TREATING HER2+ CANCER

SUPPORT

Copay Assistance

Coding and Billing

BenefitS Investigation

Prior Authorization/ Reauthorization Assistance

Coverage/Claim Appeal Assistance

Insurance AND Alternate Coverage

Patient Assistance

PATIENT BROCHURE

Copay Assistance

BenefitS Investigation

Coverage/Claim Appeal Assistance

Patient Assistance

Coding and Billing

Prior Authorization/ Reauthorization Assistance

Insurance AND Alternate Coverage

PATIENT BROCHURE

MY BIOCON BIOLOGICSTM SPECIALISTS ARE HERE TO HELP

MY BIOCON BIOLOGICSTM SPECIALISTS ARE HERE TO HELP

*Eligibility requirements apply.

BIOSIMILARITY

Multiple dosage forms help reduce waste and let you choose the right dosage form for your practice.2

150 mg single-dose vial

NDC: 83257-001-11

420 mg multi-dose vial

NDC: 83257-004-12

A FLEXIBLE ONCOLOGY

PARTNER

REFERENCES

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Cardiomyopathy

Infusion Reactions

Embryo-Fetal Toxicity

Pulmonary Toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

Most Common Adverse Reactions

INDICATIONS

Adjuvant Breast Cancer

Metastatic Breast Cancer

Metastatic Gastric Cancer

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Cardiomyopathy

Infusion Reactions

Embryo-Fetal Toxicity

Pulmonary Toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

Most Common Adverse Reactions

INDICATIONS

Adjuvant Breast Cancer

Metastatic Breast Cancer

Metastatic Gastric Cancer

You are now leaving www.OGIVRIHCP.com, a Biocon Biologics website. The website you are about to access is not owned or controlled by Biocon Biologics Inc.

You are now leaving www.OGIVRIHCP.com, a Biocon Biologics website. The website you are about to access is not owned or controlled by Biocon Biologics Inc.

You are now leaving www.OGIVRIHCP.com, a Biocon Biologics website. The website you are about to access is not owned or controlled by Biocon Biologics Inc.

INDICATIONS

Adjuvant Breast Cancer

Metastatic Breast Cancer

Metastatic Gastric Cancer

Coverage/Claim Appeal
Assistance

Coverage/Claim Appeal
Assistance

MY BIOCON BIOLOGICS^TM SPECIALISTS ARE HERE TO HELP

MY BIOCON BIOLOGICS^TM
SPECIALISTS ARE HERE TO HELP

Multiple dosage forms help reduce waste and let you choose the right dosage form for your practice.²