VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

• Ventegra® will list VEGZELMA®(bevacizumab-adcd) on its national formulary that serves more than 400 clients and more than 13 million members and patients in the U.S.
• Celltrion USA completes a contract with Ventegra to include YUFLYMA® as a preferred drug in its formulary in September 2023.
• This marks a significant step forward in offering clinically effective and cost-effective options for the oncology community in the U.S.

JERSEY CITY, N.J., Dec. 11, 2023 /PRNewswire/ -- Celltrion USA today announced that Ventegra®, a major U.S. Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model, will place an FDA-approved biosimilar to Avastin® (bevacizumab), VEGZELMA® (bevacizumab-adcd), on its commercial formulary as a preferred brand. Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

VEGZELMA was approved by the U.S. FDA in 2022 for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

"The inclusion of our FDA-approved bevacizumab biosimilar on Ventegra's preferred formulary status is another important milestone to help increase access to oncology treatment for those living with indicated cancer types across the U.S.," said Tom Nusbickel, Chief Commercial Offer at Celltrion USA. "We have been committed to introducing safe and effective biosimilars to the U.S. market because they hold tremendous promise for cost savings for patients, plans, and our entire health care system."

"Our revolutionary Medical Benefits Manager (MBM) model goes beyond traditional pharmacy benefit management to help build efficiencies, lower costs, and improve the overall quality of care. Our decision to add another Celltrion's oncology biosimilar product to our formulary supports greater affordability and access across this entire treatment class," said Robert T. Taketomo, Pharm.D., MBA, President/CEO of Ventegra. "Our partnership with Celltrion USA allows us to reach more communities faster and enable comprehensive, affordable care that improves long-term health outcomes and fosters healthier communities."

VEGZELMA® Important Safety Information

Warnings and Precautions

Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.

Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis.

Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage.

Arterial Thromboembolic Events (ATE): Discontinue for severe ATE.

Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE.

Hypertension: Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy.

Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue.

Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine.

Infusion-Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy.

Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception.

Ovarian Failure: Advise females of the potential risk.

Congestive Heart Failure (CHF): Discontinue VEGZELMA in patients who develop CHF.

Pregnancy Warning

Based on findings from animal studies and their mechanism of action, bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks. In animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects. Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Most Frequently Observed Adverse Reactions

Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Please see full Prescribing Information for VEGZELMA® (bevacizumab-adcd) 

About Celltrion USA

Celltrion USA is Celltrion Healthcare's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion Healthcare's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare endeavours to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries.  For more information, please visit: www.celltrionusa.com/

About Ventegra®

Ventegra®, recognized as a "New Class of Trade," serves as a Medical Benefit Manager ("MBM") with Pharmacy Services Administrator ("PSA") as part of its portfolio of products. Ventegra is a single, turnkey solution for clients interested in managing their medical and pharmacy benefit services with integrity, quality, and complete transparency around data/costs of care. The Ventegra business model fundamentally realigns financial incentives focusing on value-based care and total healthcare cost. Ventegra understands the value of the coordinated care delivery model and can serve the needs of those with similar goals and objectives. www.ventegra.com