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noimage Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma™ (CT-P16) 2022-06-27

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.”  - ENDS -  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].

noimage New data show statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab 2022-06-02

 New data show statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab, in patients with rheumatoid arthritis- Presented today at EULAR 2022, data from a new post-hoc analysis show a statistically significant difference in clinical outcomes with subcutaneous (SC) infliximab compared to intravenous (IV) infliximabat week 30, using conservative missing imputation methods - Data also show that differences in efficacy outcomes between SC and IV infliximab groups reduced at week 54, after the IV group switched to SC, suggesting improved responses after switching from IV to SC infliximab Wednesday 1 June 2022 - INCHEON, SOUTH KOREA– A new post-hoc analysis of a pivotal phase III randomised controlled clinical trial shows that the subcutaneous (SC) formulation of infliximab, Remsima® (CT-P13), is associated with significantly greater improvements in clinical outcomes comparedto the intravenous (IV) formulation of infliximab at week 30, in patients with rheumatoid arthritis (RA). Between-group (SC vs. IV) differences were reduced at week 54, suggesting improved responses after switching from IV to SC infliximab.[1] The data were presented today atthe Annual European Congress of Rheumatology (EULAR 2022). “It’s important for people living with rheumatoid arthritis to effectively control their disease, and when there are signs one’s RA treatment is not working as well as it used to, one might need to consider re-evaluating the treatment strategy. Today, many medications have changed the treatment landscape of rheumatology, allowing low disease activity and remission to be achieved in people with RA,” said Professor Arnaud Constantin, Rheumatologist at Rheumatology Department, Purpan University Hospital and Toulouse III – Paul Sabatier University, Toulouse, France. “Switching to medications such as the SC formulation of infliximab could allow patients to have better control of their treatment and improved quality of life.” The post-hoc study investigated whether the numerical advantage of SC infliximab compared to IV, shown in most efficacy parameters at weeks 30 and 54, was statistically significant. This was achieved using conservative imputation methods, such as non-responder imputation (NRI) and last observation carried forward (LOCF), in 343 patients who were randomised at week six into two treatment arms (165 patients received SC 120mg bi-weekly and 174 patients received IV 3mg/kg every 8 weeks). Results showed a statistically significant difference in favour of SC compared to IV-treated patients at week 30 in almost all clinical variables, including low disease activity rates and remission rate. In addition, after switching at week 30 to SC infliximab, the proportion of RA patients achieving either low disease activity rates or a ‘good response’, as measured by EULAR CRP, was increased at week 54, suggesting improved responses after switching from IV to SC. “The results presented today at EULAR provide further evidence to the efficacy of SC infliximab, as switching from IV to SC infliximab was associated with improvements in clinical response. The positive outcomes following switching from IV to SC infliximab provide reassurance to patients and the healthcare professionals who treat them,” said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. Notes to Editors: About rheumatoid arthritis[2],[3],[4],[5] Rheumatoidarthritis (RA) is a chronic inflammatory disease that causes pain, swelling and stiffness in joints. Approximately 1% of the population worldwide suffer from RA, however, the cause of it remains unknown. Symptoms of RA develop due to a faulty immune system that attacks healthy cells, but it is currently unknown why the immune system behaves in this way. Although there's no cure for rheumatoid arthritis, early treatment such as disease-modifying anti-rheumaticdrugs (DMARDs) and biological treatments can reduce the risk of joint damage and limit the impact of the condition. About CT-P13 (biosimilar infliximab)CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including Rheumatoid Arthritis (RA) and Inflammatory Bowel Disease (IBD). It was approved by the EC under the trade name Remsima® inSeptember 2013 and launched in major EU countries in early 2015. The US Food and Drug Administration (FDA) approved CT-P13 in April 2016 under the tradename Inflectra®. CT-P13 is approved in more than 98 countries (as of May 2022) including the US, Canada, Japan and throughout Europe. About Remsima® intravenous(IV) formulation[6]Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications including IBD. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.   About Remsima® subcutaneous (SC) formulation A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications in adult for the IV formulation. Remsima® SC has three available devices; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard.[6] The SC formulation has the potential to enhance treatment options for the use of infliximab by providing high consistency in drug exposure and a convenient method of administration.[7],[8]   AboutCelltrion HealthcareCelltrion 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 References 1 Arnaud Constantin, et al. Efficacy of Subcutaneous Infliximab (CT-P13 SC) Compared with Intravenous Infliximab in Rheumatoid Arthritis: A Post-hoc Analysis of a Phase 3 Randomized Controlled Trial. 2 Arthritis Research UK. Rheumatoid arthritis. Available at https://www.versusarthritis.org/about-arthritis/conditions/rheumatoid-arthritis [Last accessed May 2022]. 3 Allan Gibofsky. Overview of Epidemiology,Pathophysiology, and Diagnosis of Rheumatoid Arthritis. American Journal of Managed Care. 2012;18:S295-302. 4 Arthritis Foundation. Rheumatoid Arthritis. Available at https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/ [Last accessed May 2022]. 5 NHS UK. Treatment Available at https://www.nhs.uk/conditions/rheumatoid-arthritis/treatment/ [Last accessed May 2022]. 6 EuropeanMedicines Agency Summary of Product Characteristics (SmPC). Infliximab.  Available at https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf [Last accessed May 2022]. 7 Yoo DH, Jaworski J,Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019. 8 Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

noimage Celltrion Healthcare wins tender to supply Remsima® to the Brazilian Federal Government 2022-03-24

Celltrion Healthcare wins tender to supply Remsima®  to the Brazilian Federal Government • Remsima® is the third biosimilar product for Celltrion Healthcare to win tender in Brazil following Truxima® and Herzuma®  • The company will be supplying Remsima® (infliximab) to both the private sector and the federal and State government  • The company plans to strengthen and expand its presence leveraging its direct sales strategy in Latin America  March 24, 2022, INCHEON, KOREA – Celltrion Healthcare today announced that the company has won a tender offer by the Brazilian Federal Government for the purchase of the world’s first monoclonal antibody biosimilar Remsima® (infliximab) in Brazil. In addition, the company has won 12 State bids in Brazil to supply Remsima®, including a bid in Sao Paulo, which is the largest of Brazil's state bids. In 2021, the company has signed an agreement with the Ministry of Health to supply two of its anticancer therapeutics Herzuma® (trastuzumab) and Truxima® (rituximab) to the Brazilian market. Together with Truxima® (rituximab) and Herzuma® (trastuzumab), Remsima® (infliximab) will be the third biosimilar product that Celltrion Healthcare is to supply to the Brazilian market by winning a tender.  In addition to winning a bid for Remsima® by the Brazilian Federal Government, Celltrion Healthcare also won a tender offer by the Institute of Health for the Welfare of the United Mexican States (INSABI) for the purchase of Truxima® (rituximab) for one year. “The winning of the bid is an important milestone to broaden patient access to effective and affordable biosimilar medicines in countries like Brazil and Mexico, which are two of the biggest pharmaceutical market in Latin America,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “By supplying Remsima® (infliximab) to both the private sector and the federal and State government, we anticipate to achieve approximately two-thirds of the total Brazilian infliximab market. We have solidified our market position by exclusively supplying our biosimilar products in Peru, Chile and Costa Rica as well over the last three to four years. We are excited to adopt a direct sales strategy in the Central and South America countries in order to strengthen and expand our presence in the market and support the company’s growth.”  As part of Celltrion’s strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Brazil and Mexico to manage sales and marketing activities for its biosimilar products.  - ENDS -  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 Remsima® (biosimilar infliximab)  Remsima® is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including Rheumatoid Arthritis (RA) and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US Food and Drug Administration (FDA) approved CT-P13 in April 2016 under the trade name Inflectra®. Remsima® is approved in 96 countries (as of March 2022) including the US, Canada, Japan and throughout Europe.  About Truxima® (CT-P10, biosimilar rituximab)  Truxima® is a mAb that targets CD20, a transmembrane protein found on the surface of most B-cells. By binding specifically to CD20, Truxima® depletes B-cells by three main mechanisms: induction of apoptosis, stimulation of CDC (complement-dependent cytotoxicity) and stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity). Truxima® is approved in the EU and US for the treatment of patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. Truxima® is the first rituximab similar biotherapeutic product to be prequalified by the World Health Organization (May 2020).