CelltrionHealthcare

Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, 

Vegzelma™ (CT-P16)

• Vegzelma™ (CT-P16), a biosimilar candidate referencing Avastin®(bevacizumab)1, is Celltrion’s third oncology biosimilar to be recommended for marketing authorization by the European Medicines Agency 

• The positive opinion is based on the totality of evidence including the Phase III study to evaluate efficacy, pharmacokinetics, and safety between CT-P16 and EU-approved Avastin in people with metastatic or recurrent non-squamous non-small cell lung cancer as first-line treatment 

• Vegzelma™ (CT-P16) is recommended for the treatment of the same types of cancer as reference bevacizumab

FRIDAY 24 JUNE, 2022 - INCHEON, SOUTH KOREA – Celltrion Healthcare announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of a bevacizumab biosimilar candidate, referencing EU-approved Avastin®, Vegzelma™ (CT-P16). 

The positive CHMP opinion was supported with a comprehensive data package and totality of evidence demonstrating biosimilarity to the reference product for indications including metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer. 

The therapeutic equivalence of CT-P16 and reference bevacizumab was demonstrated by way of objective response rate (ORR) during the induction study period. In addition, CT-P16 was well tolerated and showed a comparable safety profile to reference bevacizumab.2 

“If approved, Vegzelma™ (CT-P16) will be the third therapeutic oncology biosimilar in our biosimilar pipeline,” said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. “Today’s positive CHMP opinion underscores Celltrion’s strong heritage in oncology and ongoing commitment to bringing high quality and innovative biosimilars to the market, providing additional treatment options for people living with cancers.” 

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Notes to Editors: 

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

About CT-P16 (biosimilar bevacizumab)

CT-P16 is an anti-cancer monoclonal antibody treatment developed as a candidate biosimilar to Avastin® (bevacizumab). CT-P16 (bevacizumab biosimilar) is a recombinant humanised monoclonal antibody which binds to 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. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.3 If granted authorisation, CT-P16 will be indicated for the treatment of patients with mCRC (metastatic Colorectal Cancer), NSCLC (Non-Small Cell Lung Cancer), mRCC (Metastatic Renal Cell Carcinoma), OC (Ovarian Cancer), advanced CC (Cervical Cancer), mBC (metastatic Breast Cancer). The global Phase III clinical trial is being conducted to compare efficacy and safety of CT-P16 and EU- approved Avastin® as first-line treatment for metastatic or recurrent non-squamous NSCLC. 

References

1 Avastin® is a registered trademark of Genentech Inc. 

2 Ohe Y et al., Randomized Phase III Study Comparing the Efficacy and Safety of CT-P16, a New Biosimilar, to Reference Bevacizumab (Avastin®) In Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC). Proceedings: American Association for Cancer Research (AACR) Annual Meeting 2022; April 8-13, 2022 New Orleans, Louisiana.

3 European Medicines Agency Summary of Product Characteristics (SmPC), Avastin®. Available at https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf  [Last accessed June 2022].