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REMSIMA

REMSIMA is First Antibody biosimilar approved by FDA, EMA, and others in more than 80 countries around the globe.

Remsima
INN
Infliximab
Indications
Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Adult Crohn's Disease, Psoriasis and Psoriatic Arthritis
Protein Type
Monoclonal antibody (mAb)
Mechanism of action
Neutralizes tumor necrosis factor (TNF-alpha), a pleiotropic cytokine that regulates immune responses

1. Appearance

RemsimaTM is a white, freeze-dried powder ready to be made into a solution for intravenous infusion

2. Indications and Usage

(1) RemsimaTM is a tumor necrosis factor α (TNF-α) antagonist used to treat rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn's disease, plaque psoriasis, and psoriatic arthritis. Rheumatoid Arthritis

  • RemsimaTM, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with methotrexate to severe cases of rheumatoid arthritis.

(2) Ankylosing Spondylitis

  • RemsimaTM, in combination with methotrexate for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with methotrexate to severe cases of rheumatoid arthritis

(3) Adult Crohn's Disease

  • RemsimaTM is indicated for reducing signs and symptoms as well as inducing and maintaining clinical remission in adult patients including and maintatining clinical remission in adult patients with moderate to severe cases of Crohn's disease who have had an inadequate response to conventional therapy.

(4) Ulcerative Colitis

  • RemsimaTM is indicated for reducing signs and symptoms, inducing and maintatining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderate to severe cases of ulcerative colitis who have had an inadequate response to conventional therapy.

(5) Psoriatic Arthritis

  • RemsimaTM is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.

(6) Plaque Psoriasis

  • RemsimaTM is indicated for the treatment of adult patients with chronic severe plaque psoriasis for whom other systemic therapies are medically less appropriate. Remsima should only be administered to patients who will be closely supervised and have regular follow-up visits with a physician.

3. Dosage and Administration

RemsimaTM is administered by intravenous infusion over a period of 2 hours or more.

(1) Rheumatoid Arthritis

The recommended dose of RemsimaTM is 3mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 3mg/kg every 8 weeks thereafter for the treatment of moderately to severely active rheumatoid arthritis. RemsimaTM should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 7.5mg/kg or treating as often as every 4 weeks. It should be noted that the risk of serious infection increases at higher doses.

(2) Ankylosing Spondylitis

The recommended dose of RemsimaTM is 5mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 5mg/kg every 6 weeks thereafter for the treatment of active ankylosing spondylitis.

(3) Adult Crohn's Disease

The recommended dose of RemsimaTM is 5mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 5mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn's disease or fistulzing Crohn's disease. For adult patients who experience a weakening in reponse, consideration may be given to treatment with 10mg/kg.

(4) Ulcerative Colitis

The recommended dose of RemsimaTM is 5mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 5mg/kg.

(5) Psoriatic Arthritis

The recommended dose of RemsimaTM is 5mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 5mg/kg every 8 weeks thereafter for the treatment of psoriatic arthritis. RemsimaTM can be used with or without methotrexate.

(6) Plaque Psoriasis

The recommended dose of RemsimaTM is 5mg/kg given as an intravenous induction regimen at 0,2 and 6 weeks followed by a maintenance regimen of 5mg/kg every 8 weeks thereafter for the treatment of chronic severe plaque psoriasis.

※ Product information disclaimer

The product information contained herein is based on an English translation of the Korean language product label approved by the KFDA.

HERZUMA

Herzuma ™ is an anticancer mAb biosimilar approved by EMA and MFDS

Herzuma
INN
Trastuzumab
Indication
HER2 positive metastatic breast cancer, early cancer, and metastatic gastric cancer
Protein Type
Monoclonal antibody (mAb)
Mechanism of Action
The antibody specifically binds to the antigen and suppresses the antigen signals to target and destroy tumor

1. Appearance

Powder for concentrate for solution for infusion. White to pale yellow lyophilised powder.

2. Indications and Usage

(1) Breast cancer

Metastatic breast cancer

Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):

as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments

  • in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable
  • in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
  • in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone receptor-positive MBC, not previously treated with trastuzumab
Early breast cancer

Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):

  • following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)
  • following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel
  • in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin
  • in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter

Herzuma should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

(2) Metastatic gastric cancer

Herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herzuma should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

3. Dosage and Administration

(1) Breast cancer

Metastatic breast cancer
  • Three-weekly schedule
    The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
  • Weekly schedule
    The recommended initial loading dose of Herzuma is 4 mg/kg body weight. The recommended weekly maintenance dose of Herzuma is 2 mg/kg body weight, beginning one week after the loading dose.
  • Administration in combination with paclitaxel or docetaxel
    In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
  • Administration in combination with an aromatase inhibitor
    In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1. There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).
Early breast cancer
  • Three-weekly and weekly schedule
    As a three-weekly regimen the recommended initial loading dose of Herzuma is 8 mg/kg body weight. The recommended maintenance dose of Herzuma at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
    As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.

(2) Metastatic gastric cancer

  • Three-weekly schedule
    The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.

(3) Breast cancer and gastric cancer

  • Duration of treatment
    Patients with MBC or MGC should be treated with Herzuma until progression of disease. Patients with EBC should be treated with Herzuma for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended
  • Dose reduction
    No reductions in the dose of Herzuma were made during clinical trials. Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
    If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks. If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herzuma should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. All such patients should be referred for assessment by a cardiologist and followed up.
  • Missed doses
    If the patient has missed a dose of Herzuma by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible. The patient who missed the dose should not wait until the next planned cycle. Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
    If the patient has missed a dose of Herzuma by more than one week, a re-loading dose of Herzuma should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible. Subsequent Herzuma maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.

TRUXIMA

Truxima is First mAb biosimilar in oncology granted by EMA and MFDS

Truxima
INN
Rituximab
Indications
Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
Protein Type
Monoclonal antibody (mAb)
Mechanism of action
Targets the CD20 antigen expressed on the surface of B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis.

1. Appearance

Solution for injection. Clear to opalescent, colourless to yellowish liquid.

2. Indications and Usage

(1) Non-Hodgkin's lymphoma

  • Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy.
  • Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.
  • Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

(2) Chronic lymphocytic leukaemia

  • Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy.

(3) Rheumatoid arthritis

  • Truxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Truxima has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with methotrexate.

(4) Granulomatosis with polyangiitis and microscopic polyangiitis

  • Truxima, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).

3. dosage and Administration

Truxima should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Truxima.
In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Truxima is not given in combination with glucocorticoid-containing chemotherapy.
In patients with rheumatoid arthritis, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Truxima infusions to decrease the incidence and severity of infusion related reactions (IRRs).

In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Truxima (the last dose of methylprednisolone may be given on the same day as the first infusion of Truxima). This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after Truxima treatment.

(1) Non-Hodgkin's lymphoma

(1-1) Follicular non-Hodgkin's lymphoma

Combination therapy

  • The recommended dose of Truxima in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles. Truxima should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.

Maintenance therapy

  • Previously untreated follicular lymphoma
    The recommended dose of Truxima used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until diseaseprogression or for a maximum period of two years.
  • Relapsed/refractory follicular lymphoma
    The recommended dose of Truxima used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years.

Monotherapy

  • Relapsed/refractory follicular lymphoma
    ㆍThe recommended dose of Truxima monotherapy used as induction treatment for adult patients with stage III IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
    ㆍFor retreatment with Truxima monotherapy for patients who have responded to previous treatment with Truxima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks (seesection 5.1).

(1-2) Diffuse large B cell non-Hodgkin's lymphoma

Truxima should be used in combination with CHOP chemotherapy. The recommended dosage is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP. Safety and efficacy of Truxima have not been established in combination with other chemotherapies in diffuse large B cell non Hodgkin's lymphoma.

No dose reductions of Truxima are recommended. When Truxima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.

(2) Chronic lymphocytic leukaemia

Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome. For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administerprednisone/prednisolone 100 mg intravenous shortly before infusion with Truxima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.

The recommended dosage of Truxima in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total. The chemotherapy should be given after Truxima infusion.

(3) Rheumatoid arthritis

  • Patients treated with Truxima must be given the patient alert card with each infusion.
    A course of Truxima consists of two 1000 mg intravenous infusions. The recommended dosage of Truxima is 1,000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
  • The need for further courses should be evaluated 24 weeks following the previous course. Retreatment should be given at that time if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns.
    Available data suggest that clinical response is usually achieved within 16 – 24 weeks of an initial treatment course. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.

(4) Granulomatosis with polyangiitis and microscopic polyangiitis

  • Patients treated with Truxima must be given the patient alert card with each infusion.
    The recommended dosage of Truxima for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
    Pneumocystis jiroveci pneumonia (PCP) prophylaxis is recommended for patients with granulomatosis with polyangiitis or microscopic polyangiitis during and following Truxima treatment, as appropriate.
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