Celltrion

Celltrion USAreceives U.S. FDA approval for its oncology biosimilar Vegzelma^® (bevacizumab-adcd) for the treatment of six types of cancer

·         Vegzelma^® is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDA

·         Vegzelma^® offers U.S. patients living with multiple types of cancer a new, safe, and effective treatment option

·         The approval is based on totality of evidence with no clinically meaningful differences in efficacy or safety with the reference product Avastin^®(bevacizumab)

September 28, 2022, CHICAGO, IL ?Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Vegzelma^® (bevacizumab-adcd), a biosimilar to Avastin^® (bevacizumab)[1], for the treatment ofsix 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.

“Biosimilars have been used in many disease areas including oncology, and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Professor Claire Verschraegen, Director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center, Columbus, OH. “With the availability of biosimilars such as Vegzelma^® in the U.S., oncologists will have additional treatment options for patients across multiple cancer types.”

The FDA approval of Vegzelma^® was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. Results showed that as a first-line treatment, Vegzelma^® is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.[2]

“The approval of Vegzelma^® is an important milestone in the U.S. which adds to our growing portfolio of oncology treatments and marks an important step forward in expanding access to cancer care,” said Jaeik Shim, Chief Operating Officer at Celltrion USA.  “As a leading force in the global biopharmaceutical industry, we look forward to working with payers and providers to make our product available to patients. With our high-quality and affordable biosimilar medicines, we plan to strengthen our presence in the U.S. and contribute to a more sustainable healthcare system for the future.”

Vegzelma^® is Celltrion’s third oncology biosimilar approved for use in the U.S., following the approval of Truxima^® (rituximab-abbs) and Herzuma^® (trastuzumab-pkrb). Vegzelma^® was approved in the EU in August 2022 and UK and Japan in September 2022. Regulatory reviews are ongoing in additional countries.

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Notes to Editors:

About Vegzelma^® (CT-P16, biosimilar bevacizumab-adcd)²
Vegzelma^®is an anti-cancer monoclonal antibody treatment biosimilar to Avastin^® (bevacizumab). Vegzelma^®is a recombinant humanized monoclonal antibody which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells.  In the U.S., Vegzelma^® is indicated for the treatment of patients with metastatic colorectal cancer (mCRC); recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma (GBM); metastatic renal cell carcinoma (mRCC); persistent, recurrent, or metastatic cervical cancer (CC); epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vegzelma^® Important Safety Information[3]

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 Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. 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: https://www.celltrionhealthcare.com/en-us.

About Celltrion USA

Celltrion USA is Celltrion Healthcare’s U.S. subsidiary dedicated to the distribution of Celltrion’s small molecule pharmaceutical products and biosimilar products within the U.S. Celltrion USA started its business as a brand and generic pharmaceutical product distributor and expanded its portfolio to COVID-19 test kits. Celltrion USA will be dedicating its resources to biosimilar product launches in the U.S.

FORWARD-LOOKING STATEMENT

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