FAQ

  • Marketing Q1. What is the difference between Remsima™1) and Inflectra™?

    Remsima™ and Inflectra™ are both brand names of the biosimilar infliximab developed and manufactured by Celltrion, Inc. Celltrion Healthcare conducts the product’s sales, marketing, and distribution through its global partners. Inflectra™ is the brand name used by Hospira (Pfizer’s company) whereas Remsima™ is used by other partners.

    1) Remsima™: CT-P13, also known as Inflectra™ and infliximab-dyyb

  • Marketing Q2. How are biosimilars evaluated in the EU?

    As of Jan, 2017, Remsima™(also known as Inflectra™) has been approved in 79 countries worldwide.

  • Marketing Q3. In which diseases is Remsima™ indicated?

    Remsima™ is approved for all the indications currently covered by the Reference Infliximab by EMA (European Medicines Agency) and Health Canada. Also, Inflectra™ is approved for adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis by U.S. FDA (Food and Drug Administration)2).

    2) Remicade™'s pediatric UC indication is protected by orphan exclusivity through 23 September 2018

    The full therapeutic indications for Remsima™ are as follows:

    Rheumatoid arthritis
    Remsima™, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
    • adult patients with active disease when the response to disease modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;
    • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

    Adult Crohn’s disease
    Remsima™ is indicated for:
    • treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to, or have medical contraindications for, such therapies;
    • treatment of fistulising, active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

    Pediatric Crohn’s disease
    Remsima™ is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy, including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.

    Ulcerative colitis
    Remsima™ is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

    Pediatric ulcerative colitis
    Remsima™ is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

    Ankylosing spondylitis
    Remsima™ is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

    Psoriatic arthritis
    Remsima™ is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
    Remsima™ should be administered:
    • in combination with methotrexate;
    • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.

    Psoriasis
    Remsima™ is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, who have a contraindication to or are intolerant to, other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A.

  • Marketing Q4. What is Celltrion Healthcare?

    Celltrion Healthcare conducts the global marketing and sales activities for the distribution of Celltrion, Inc.'s biopharmaceutical products through its global network of more than 120 different countries.

  • Marketing Q5. What is the company’s business focus?

    Celltrion Healthcare’s business focus is promoting global health and welfare by delivering high quality, affordable biopharmaceuticals to patients worldwide. Celltrion, Inc. focuses on developing these medicines in the fields of immunology, oncology and virology.

    We are guided by our core value: to provide advanced care to patients with life-changing conditions, with respect and value for the communities we serve.

  • Medical Q1. What is a biosimilar medicine?

    A biosimilar medicine is a biological medicine that has been developed to be similar to an existing, approved biological medicine that contains the same active ingredient (Reference Infliximab, reference medicine, biological reference medicine, originator).

    A biological medicine is a medicine that contains one or more active substances made by or derived from a biological source. As with biological medicines, a biosimilar is developed and approved via stringent regulatory pathways.

    Biosimilars are not the same as generics. Generics are considered to be identical to their Reference infliximab. The complexity of originator biologics and biosimilars, as well as the way they are produced in living organisms, means that there will be a certain degree of variability in molecules of the same active substance in different batches of the biological medicine. This applies to both the reference biologics and biosimilars.

    Biosimilars are rigorously assessed in clinical trials to demonstrate the similar nature, in terms of quality, safety and efficacy, of the biosimilar and its approved Reference infliximab. To gain approval, the variability and any differences between a biosimilar and its Reference infliximab must be shown not to affect safety or effectiveness. Once it has been demonstrated that there is no meaningful clinical difference between a biosimilar and its Reference infliximab (comparability or bioequivalence), the biosimilar can generally be used at the same dose to treat the same diseases as the Reference infliximab.

    Biosimilars can only be authorized for use once the period of data exclusivity on the Reference infliximab has expired. In general, this means that the Reference infliximab must have been authorized for at least 10 years before a similar biological medicine can be made available by another company.

  • Medical Q2. How are biosimilars evaluated in the EU?

    Biosimilars must follow the general scientific guidelines related to originator biological medicinal products and undergo the same rigorous regulatory assessment by the relevant regulatory authorities.

    Regulatory agencies require that biosimilars demonstrate equivalent efficacy and safety to the Reference Infliximab and are then generally used at the same dose to treat the same conditions. Because the Reference Infliximab of the biosimilar has been authorized for several years and its clinical benefit is established, some studies carried out with the Reference Infliximab may not need to be reproduced.

    Although more than 10 first generation biosimilars have been approved since 2006, Remsima™ was the first biosimilar monoclonal antibody to be approved by the EMA. Remsima™ demonstrated comparability to its Reference Infliximab in efficacy and safety. Therefore, the EMA has acknowledged the efficacy and safety of Remsima™ as equivalent to its Reference Infliximab, and a suitable alternative for prescription to patients.

    Europe is the frontrunner in the biosimilar arena, having had an established biosimilar approval pathway in place since 2003. In 2012 the EMA published guidance on the non-clinical and clinical requirements for biosimilar monoclonal antibodies, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficacy, and safety studies. Then in 2013, the agency issued a draft concept paper on the comparison of biosimilars with Reference Infliximabs.

    Once clinical trials have demonstrated the similar nature, in terms of quality, safety and efficacy, of a biosimilar and its approved Reference Infliximab, the biosimilar can generally be used at the same dose to treat the same diseases as the Reference Infliximab. For this reason, the clinical data in rheumatoid arthritis and ankylosing spondylitis provided the EMA with the required evidence to approve Remsima™ in all of its eight indications.

  • Medical Q3. What data were used for the approval of Remsima™?

    Approval of Remsima™ was based on the PLANETRA and PLANETAS studies which compared the efficacy and safety of Remsima™ with the Reference Infliximab in rheumatoid arthritis and ankylosing spondylitis patients, respectively.

    Once clinical trials have demonstrated the similar nature, in terms of quality, safety and efficacy, of a biosimilar and its approved Reference Infliximab, the biosimilar can generally be used at the same dose to treat the same diseases as the Reference Infliximab. For this reason, the clinical data in rheumatoid arthritis and ankylosing spondylitis provided the EMA with the required evidence to approve Remsima™ in all of its eight indications.

    PLANETRA study
    The PLANETRA study was a phase III, randomized, double-blind, multicenter, multinational, parallel-group study in 606 patients with RA. Patients with active disease who had experienced an inadequate response to methotrexate (MTX) were randomized to receive 3 mg/kg of Remsima™ (n=302) or the Reference Infliximab (n=304) with MTX and folic acid for 30 weeks. The primary endpoint was the change in symptoms as measured by the American College of Rheumatology 20% (ACR20) response at week 30. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), as well as pharmacokinetic and pharmacodynamic parameters, safety and immunogenicity.

    After 30 weeks of treatment Remsima™ was comparable to the Reference Infliximab in symptom reduction, with around 60% of patients responding to treatment with either medicine. Remsima™ also demonstrated a comparable safety profile to that of the Reference Infliximab.

    PLANETAS study
    The PLANETAS study was a phase 1, randomized, double-blind, multicenter, multinational, parallel-group study, in which Remsima™ was compared with infliximab in a study involving 250 patients with AS. Patients were randomized to receive 5 mg/kg of Remsima™ (n=125) or the Reference Infliximab (n=125). Primary endpoints were area under the concentration-time curve (AUC - a measure used in estimating bioavailability of drugs, and in estimating total clearance of drugs) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional pharmacokinetic and efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Remsima™ was shown to produce levels of the active substance in the body that were comparable to the Reference Infliximab, and equivalent pharmacokinetic profiles. Remsima™ was well tolerated, with an efficacy and safety profile comparable to that of the Reference Infliximab up to week 30.

  • Medical Q4. Can a biosimilar be substituted/switched with an originator biologic?

    With clinical trial results demonstrating comparability and with no significant difference in terms of efficacy and safety, a biosimilar is considered to be comparable to its Reference Infliximab.

    Regulatory agencies, such as the EMA and FDA, have different perspectives on prescribing biosimilar medicines to those who are already taking the Reference Infliximab.

    The EMA’s current position is that that decisions on interchangeability and/or substitution rely on national competent authorities and are outside the remit of EMA/CHMP; the Member States have access to the scientific evaluation performed by the CHMP and all submitted data in order to substantiate their decisions.

    The position of the FDA is that, to meet the higher standard of “interchangeability,” an applicant must provide sufficient information to demonstrate biosimilarity, and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient. Recently, data from extension phases of the two clinical trials (PLANETRA and PLANETAS) have been published in Annals of the Rheumatic Diseases. The data show that it is possible to switch from the Reference Infliximab to Remsima™ without any detrimental effects on safety or efficacy. The studies also show that CT-P13 is well tolerated and effective for up to two years in patients with RA and AS

    In addition, the NOR-SWITCH Study was designed to assess the safety and efficacy of switching from the Reference Infliximab to Remsima™ in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis. The study is being will be undertaken in 18 hospitals across in Norway and aims to recruit 500 people. Data from this study are expected in 2016.

  • Medical Q5. Why would a physician choose to use a biosimilar rather than the Reference Infliximab?

    Since their introduction, originator biologics have had a positive impact on patient outcomes. However, their high cost places a considerable burden on healthcare systems, and can affect patient access to treatment. Biosimilars therefore have the potential to offer considerable cost savings to health services, especially as they are often used to treat long-term conditions. They can also increase the number of patients who have access to biological therapies.

    Research has shown that between 2007 and 2020 the use of biosimilars is expected to result in overall savings of between €11.8 billion and €33.4 billion, with biosimilar mAbs producing the greatest savings ranging from €1.8 to €20.4 billion.

    An evaluation of the budget impact of the introduction of Remsima™ in the treatment of rheumatoid arthritis demonstrated that the total five year cost saving across UK, Italy, Germany and France would range from €96 million to €433 million. A further budget impact study has analyzed the substantial cost savings associated with the introduction of Remsima™ in Crohn’s disease. The model showed that the total five year saving across UK, Italy and France ranged from €76 million to €336 million.

  • Career Q1. Where can I find the recruitment announcement?

    Our HR team runs a talent pool. This keeps track of your record and contact you directly once the new job opening is available

  • Career Q2. How can I register a talent pool?

    You can submit your C.V. [Careers > Recruitment Process].

  • Career Q3. Can past applicants re-apply?

    There is no limitation to the number of times an applicant may apply.

  • Career Q4. Can experienced applicants apply as an entry level?

    It is possible. However, please remember the past experience will not be acknowledged.

  • Career Q5. Is it possible to apply for more than one position?

    It is possible to apply between affiliates.

  • Career Q6. Is it possible to apply via e-mail or visit?

    Only online apply is available.

  • Career Q7. Is there any limitation on gender or age for applying?

    There is no limitation.

  • Career Q8. Is master’s and doctor’s degree acknowledged as the past experience?

    The post-graduate degree is acknowledged as the past experience.

  • Career Q9. Can an applicant who has not studied the major which is guided on the application guideline?

    The guided major is chosen considering the adaptability and suitability for the position.
    Although you have not studied the specific major, you can apply for the position if you have enough interest and experience on the job.

  • Career Q10. Can I submit the expired official language proficiency report?

    No, only the report within the validity period is acceptable.

  • Career Q11. Does a holder of oversea degree have to submit the official language proficiency report?

    In case of a four year college graduates abroad, you are not required to submit a separate report.

  • Career Q12. Is there any internship program or any other industry professional practice program?

    If necessary, it is proceeded with a separate recruitment announcement.

  • Career Q13. How is the interview conducted?

    The general interview process is conducted in several stages.
    1st stage : Foreign language capability (English/Second language, if possible)
    2nd stage : In-depth job interview (presentation/discussion)
    3rd stage : Personality / Adaptability interview

  • Career Q14. How long will it take for an interview?

    It takes 30 min to 1 hour by each stage.

  • Career Q15. Do you notify the interview result?

    We make notification of the results of each interview stage by email after reviewing is completed.
    If you have not received an email, there is a high probability that you registered the incorrect email address upon filing your application. If not, please check result on the website.

  • Career Q16. Do you provide a dormitory?

    There is no company dormitory.

  • Career Q17. How long is the probationary period?

    The probationary period is 3 months.

  • Career Q18. Where can I inquire questions regarding the recruitment?

    You can ask questions on the website at [Careers > Recruitment Process]. The person in charge will respond you within 3~5days.