CA-CELLTRION

Celltrion today announced the company’s vision for the next decade at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, USA. Celltrion’s Chairman Jung Jin Seo outlined the company’s strategic transition: Celltrion expects to transform from a ‘first mover’ to a ‘game changer’ by 2030.

Celltrion’s strategy is anticipated to differentiate the company in the biosimilars landscape, building on its existing portfolio of treatments, including value added medicines or bioinnovatives such as Remsima^® SC, the world’s first subcutaneous formulation of infliximab. Remsima^® SC has the potential to offer an alternative personalised and convenient treatment option and was approved by the European Commission for patients with rheumatoid arthritis in November 2019. Celltrion Healthcare, the distribution arm of Celltrion, has also applied for a further extension to the marketing authorization of Remsima^® SC, to include the inflammatory bowel disease indication. This approval decision is expected in mid-2020.

Jung Jin Seo, Celltrion’s Chairman, said ‘‘Celltrion boasts a strong and dynamic product portfolio and pipeline. As we chart the company’s 2030 vision, the company hopes to launch one biosimilar product every year, reaching a total number of 18 products by 2030. Biosimilars and value added medicines which we call ‘bioinnovatives’ (innovative biosimilars) are set to be our key growth drivers in 2020. We plan to enter the new drugs and ubiquitous-healthcare business sector towards 2030.”

Celltrion expects a number of significant factors will positively influence biosimilar uptake and the company’s growth in the coming years, including healthcare budgetary pressures; growing demand for low-cost alternative medicines and an increase in prescriptions for biologics. These factors have played a role in the growth of the biosimilar industry in recent years. Celltrion’s Chairman highlighted that increasingly positive sentiment from key stakeholders has contributed to Celltrion Healthcare’s growth in sales over the course of 2019 and is set to continue.

As demonstrated by the findings of a recent report from healthcare consulting firm IQVIAⁱ , the company’s market share in major European markets has continued to grow. Remsima^® , the world’s first approved monoclonal antibody biosimilar has continued to overtake the market share of its reference drug, Janssen’s Remicade^® , with Remsima^® owning 59% of the market. Celltrion has also seen growth in the uptake of its rituximab biosimilar, Truxima^® and trastuzumab biosimilar, Herzuma^® , with their market shares reaching 38% and 15% respectively. These figures place Truxima^® and Herzuma^® as the leading biosimilars in terms of market share within the rituximab and trastuzumab markets.

Ho Ung Kim, Head of the Medical and Marketing Division at Celltrion Healthcare said, “As a ‘first mover’ , Celltrion Healthcare has gained extensive experience in the biopharmaceutical field and is now ready to initiate a direct sales model. Celltrion Healthcare has set up its own sales network and overseas offices in 14 countries throughout Europe to secure price competitiveness, and strives to lead the global tumour necrosis factor alpha (TNF-α) inhibitors market with its innovative infliximab Remsima^® SC, which is projected to be worth approximately $50 billion.”

As Celltrion enters the next decade, its ambitions reach beyond biosimilars and into new drug development. At the conference, Jung Jin Seo also outlined the company’s new drug development plan which is set to combine new platform technology and drug repositioning. This platform technology - the Antibody Delivery Enhancing Domain - is designed to increase the delivery efficiency of antibody-drug conjugates and their cell penetration, which has the potential to enhance cancer treatments. The company is set to create a new paradigm following innovation trends throughout the healthcare sector from 2020 to 2030.

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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 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 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

About CT-P13 (biosimilar infliximab)^{ii ,iii ,iv}

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 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 U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra^® . CT-P13 is approved in more than 89 countries (as of January 2020) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. 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. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 SC has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion has submitted a further variation to the marketing authorization of CT-P13 SC to extend the indication to inflammatory bowel disease. In the United States, Remsima^® SC will be reviewed through the new drug pathway with the expectation of receiving US Food and Drug Administration (FDA) approval by 2022.

About ‘bioinnovatives’

‘Bioinnovatives’ are defined by Celltrion Healthcare as ‘innovative biosimilars’. The term derives from the combination of the words ‘biosimilar’ and ‘innovation’.

While biosimilars, as the term suggests, aim to establish similarity to a known biologic; Celltrion Healthcare considers ‘bioinnovatives’ as ‘value added medicines’. Medicines for Europe define ‘value added medicines’ as biosimilars which address additional healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers. The ‘added value’ may be achieved through finding a new indication (drug repositioning), finding a better formulation or dosage (drug reformulation), or developing a combined drug regimen, adding a new device or providing a new service (drug combination). Relevant improvements include: a better efficacy, safety and/or tolerability profile; a better method of administration and/or ease of use; and new therapeutic uses (indication/population).^v

References

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ⁱ IQVIA WRP 2019. Data on File.

ⁱⁱ 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.

ⁱⁱⁱ 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.

^iv European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf [Last accessed January 2020].

^v European Medical Advisory Board on Value Added Medicines. Perceptions and recommendations of physicians/ KOLs on value added medicines. 2019. Available at https://www.medicinesforeurope.com/wp-content/uploads/2019/11/Advisory-board_report-exec-summary_final.pdf [Last accessed January 2020]

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