CelltrionHealthcare

‘FirstMover to Game Changer’: Celltrion announces 2020-2030 

strategy at the 38^thJ.P. Morgan Healthcare Conference

·       Celltrion’s Chairman JungJin Seo announced the company’s strategy for the upcoming decade including itsbiosimilar, bioinnovative and new drug portfolio

JANUARY 15^th 2020, 16:00 PST, SAN FRANCISCO, USA – Celltriontoday announced the company’s vision for the next decade at the 38th AnnualJ.P. Morgan Healthcare Conference in San Francisco, USA. Celltrion’s ChairmanJung Jin Seo outlined the company’s strategic transition: Celltrion expects to transformfrom a ‘first mover’ to a ‘game changer’ by 2030.

Celltrion’sstrategy is anticipated to differentiate the company in the biosimilarslandscape, building on its existing portfolio of treatments, including valueadded medicines or bioinnovatives such as Remsima^® SC, the world’sfirst subcutaneous formulation of infliximab. Remsima^® SC has thepotential to offer an alternative personalised and convenient treatment optionand was approved by the European Commission for patients with rheumatoidarthritis in November 2019. Celltrion Healthcare, the distribution arm ofCelltrion, has also applied for a further extension to the marketingauthorization of Remsima^® SC, to include the inflammatory boweldisease indication. This approval decision is expected in mid-2020.

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

Celltrionexpects a number of significant factors will positively influence biosimilaruptake and the company’s growth in the coming years, including healthcarebudgetary pressures; growing demand for low-cost alternative medicines and anincrease in prescriptions for biologics. These factors have played a role inthe growth of the biosimilar industry in recent years. Celltrion’s Chairman highlightedthat increasingly positive sentiment from key stakeholders has contributed toCelltrion Healthcare’s growth in sales over the course of 2019 and is set tocontinue.

Asdemonstrated by the findings of a recent report from healthcare consulting firmIQVIA[i], the company’s marketshare in major European markets has continued to grow. Remsima^®, theworld’s first approved monoclonal antibody biosimilar has continued to overtakethe market share of its reference drug, Janssen’s Remicade^®, withRemsima^® owning 59% of the market. Celltrion has also seen growth inthe uptake of its rituximab biosimilar, Truxima^® and trastuzumabbiosimilar, 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 andtrastuzumab markets.

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

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

- ENDS -

Notes to Editors:

About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordablemedications to promote patients’ access to advanced therapies. Its products aremanufactured at state-of-the-art mammalian cell culture facilities, designedand built to comply with the US FDA cGMP and the EU GMP guidelines. CelltrionHealthcare endeavours to offer high-quality cost-effective solutions through anextensive global network that spans more than 120 different countries. For moreinformation 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’sfirst monoclonal antibody biosimilar approved by the European Commission (EC).It is indicated for the treatment of eight autoimmune diseases including RA andIBD. It was approved by the EC under the trade name Remsima^® inSeptember 2013 and launched in major EU countries in early 2015. The U.S. Foodand Drug Administration approved CT-P13 in April 2016 under the trade nameInflectra^®. 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 5mgper kg/body weight for the other indications. Infliximab IV is given as aninfusion over two hours. All patients are monitored for any reactions duringthe infusion and for at least one to two hours afterwards. Celltrion has alsodeveloped a subcutaneous (SC) formulation of infliximab that has threeadministration options; via a pre-filled pen (auto injector), pre-filledsyringe or pre-filled syringe with needle safeguard. The SC formulation has thepotential to enhance treatment options for the use of infliximab biosimilar byproviding high consistency in drug exposure and a convenient method ofadministration.

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

About ‘bioinnovatives’

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

While biosimilars, as the term suggests, aim to establish similarityto a known biologic; Celltrion Healthcare considers ‘bioinnovatives’ as ‘valueadded medicines’. Medicines for Europe define ‘value added medicines’ as biosimilarswhich address additional healthcare needs and deliver relevant improvements forpatients, healthcare professionals and/or payers. The ‘added value’ may beachieved through finding a new indication (drug repositioning), finding abetter formulation or dosage (drug reformulation), or developing a combineddrug regimen, adding a new device or providing a new service (drugcombination). Relevant improvements include: a better efficacy, safety and/ortolerability profile; a better method of administration and/or ease of use; andnew therapeutic uses (indication/population).[v]

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