CelltrionHealthcare

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 of physical function for:

• adult patients with active arthritis when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;

• adult patients with severe, active, and progressive arthritis not previously treated with methotrexate or other DMARDs. It was observed that Remsima® slowed down the progression of joint damage in this group of patients at the time of the X-ray evaluation.

■ Adult Crohn’s disease

Remsima® is indicated for:

• the treatment of moderately to severely active Crohn’s disease for 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; and

• the treatment of fistulising, active Crohn’s disease for adult patients who have not responded despite a full and adequate course of therapy with conventional treatments such as antibiotics, drainage, and immunosuppressive therapy.

■ Pediatric Crohn’s disease (in children and adolescents ages 6 to 17)

Remsima® is indicated for the treatment of severe, active Crohn’s disease in children and adolescents ages 6 to 17, who have not responded to conventional therapies, including corticosteroid, immunomodulatory, and primary nutrition therapies; 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 the treatment of moderately to severely active ulcerative colitis for 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 (for children and adolescents ages 6 to 17)

Remsima® is indicated for the treatment of severely active ulcerative colitis in children and adolescents ages 6 to 17, 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 the treatment of severe, active ankylosing spondylitis for adult patients who have responded inadequately to conventional therapy with an increase in serologic markers associated with inflammation.

■ Psoriatic arthritis

Remsima® is indicated for the treatment of active and progressive psoriatic arthritis for adult patients when the response to previous DMARD therapy has been inadequate.

Remsima® should be administered:

• in combination with methotrexate; or

• by itself for patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.

• It is effective in improving the physical function of patients with psoriatic arthritis. An X-ray evaluation shows that it can also slow down the progression of peripheral joint damage of those with symmetrical polyarthritis.

■ Psoriasis

Remsima® is indicated for the treatment of moderate to severe plaque psoriasis for adult patients who failed to respond to, who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate, or psoralen ultra-violet A (PUVA).

Remsima® was approved based on the results of the PLANETRA and PLANETAS trials, which compared its efficacy and safety with the reference infliximab in rheumatoid arthritis and ankylosing spondylitis patients, respectively.

The PLANETRA trial was a phase III, randomized, double-blind, multicenter, multinational, parallel-group study in 606 patients with rheumatoid arthritis (RA). After 30 weeks of treatment, Remsima® was comparable to the reference infliximab in symptom reduction, with around 60% of patients responding to the treatment with either medicine. Remsima® also demonstrated a similar safety profile to that of the reference infliximab.

The PLANETAS trial was a group study involving 250 patients with ankylosing spondylitis (AS) in which Remsima® was compared with reference infliximab. Remsima® was found to maintain the 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 similar to that of the reference infliximab up to week 30.

Remsima® has been approved for sale in about 110 countries across the world(As of third quarter of 2019). 

Remsima® and Inflectra® refer to the same biosimilar infliximab developed and manufactured by Celltrion Inc. but with different brand names. Inflectra® is the brand name used in the U.S. market by Celltrion Healthcare’s global partner Pfizer. 

The full therapeutic indications for Truxima® are as follows:

■ Lymphoma

Truxima® can be indicated:

• for the treatment of follicular lymphoma (including types B, C, and D of B-cell non-Hodgkin lymphoma in the IWF classification) for patients prone to relapse or intolerant to chemotherapy;

• in combination with chemotherapy for patients with follicular lymphoma who have never received treatment before;

• as maintenance therapy after carrying out an induction therapy for patients with follicular lymphoma; or

• in combination with CHOP chemotherapy (an eight-week combination treatment involving cyclophosphamide, doxorubicin, vincristine, and prednisolone) for patients with CD20-positive diffuse large B-cell lymphoma (DLBCL).

■ Chronic Lymphocytic Leukemia

• Truxima® should be administered in combination with chemotherapy for patients who have never received treatment before or suffer from relapsed/refractory chronic lymphocytic leukemia.

■ Rheumatoid Arthritis

Truxima® can be indicated:

• in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis for patients when the response to one or more previous TNF therapy sessions have been inadequate; or

• in combination with methotrexate to slow down the joint damage (shown through an X-ray text) and improve the physical function of patients.

■ Wegener granulomatosis and microscopic polyangiitis

• Truxima® should be administered in combination with glucocorticoid for adult patients with Wegener granulomatosis (WG) and microscopic polyangiitis (MPA).

Truxima® was proven equivalent to the reference rituximab in a bioequivalence test that involved evaluating the response rate of 258 patients with low-tumor-burden follicular lymphoma (LTBFL) from 23 countries at 7 months. Furthermore, Truxima® was well tolerated, with an efficacy and immunogenicity profile similar to that of the reference rituximab.

Truxima® was also considered comparable to the reference rituximab in a bioequivalence test that involved 140 patients with advanced follicular lymphoma (AFL) from 20 countries. It turned out to be similar to the reference rituximab in terms of its safety profile.

Truxima® has been approved for sale in about 60 countries across the world(As of third quarter of 2019). 

The full therapeutic indications for Herzuma® are as follows:

■ Metastatic breast cancer

• For the treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, Herzuma® should be administered:

• by itself for patients who have had chemotherapy once or more for the treatment of metastatic diseases;

• in combination with paclitaxel or docetaxel for patients who have never had chemotherapy for the treatment of metastatic diseases; or

• in combination with an aromatase inhibitor for postmenopausal patients with hormone receptor-positive breast cancer who have never had trastuzumab injection.

■ Early breast cancer

• For the treatment of HER2-positive early breast cancer, Herzuma® should be administered:

• for patients before or after surgery or after chemotherapy (radiotherapy if necessary);

• in combination with paclitaxel or docetaxel for patients after chemotherapy with doxorubicin and cyclophosphamide;

• in combination with adjuvant chemotherapy with docetaxel and carboplatin; or

• in combination with neoadjuvant chemotherapy before surgery and by itself as adjuvant therapy after surgery for the treatment of locally advanced diseases (including inflammatory ones) and/or larger than 2-centimeter tumor in diameter.

■ Metastatic gastric cancer

• Herzuma® should be administered in combination with platinum anticancer drugs and capecitabine or with Fluorouracil (5-FU) for patients with HER2-positive metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have never had cancer treatment for metastatic diseases.

Herzuma® underwent a bioequivalence test that involved 549 patients with early breast cancer across 112 medical centers from 23 countries to see how similar it is to the reference trastuzumab. According to the clinical results, it was proven comparable to the reference trastuzumab after studying the total pathological complete response (tpCR) rate approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

In addition, Herzuma® achieved similar outcomes to those of the reference trastuzumab, demonstrating demographical and pathological characteristics common in treatment groups. It also turned out to be similar to the reference trastuzumab in terms of its safety profile.

Herzuma® has been approved for sale in about 50 countries across the world(As of third quarter of 2019).