European Union - English - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancerogivri 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 treatmentsin 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 suitablein combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic diseasein combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancer                     ogivri 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 docetaxelin combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.ogivri should only be used in patients with metastatic or ebc whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancerogivri 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 gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.ogivri 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.

European Union - English - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - etanercept - arthritis, rheumatoid; arthritis, juvenile rheumatoid; arthritis, psoriatic; spondylarthropathies; spondylitis, ankylosing; psoriasis - immunosuppressants - rheumatoid arthritisnepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.nepexto, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.juvenile idiopathic arthritistreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.etanercept has not been studied in children aged less than 2 years.psoriatic arthritistreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease.axial spondyloarthritisankylosing spondylitis treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.non-radiographic axial spondyloarthritis treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (nsaids).plaque psoriasistreatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-a light (puva).paediatric plaque psoriasistreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

European Union - English - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastic agents - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status, please refer to section 5.1.abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. for further information as to her2 status, please refer to section 5.1.abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5.1).abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5.1).abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

Canada - English - Health Canada

biosimilar collaborations ireland limited - pegfilgrastim - solution - 10mg - pegfilgrastim 10mg - hematopoietic agents

Canada - English - Health Canada

biosimilar collaborations ireland limited - bevacizumab - solution - 400mg - bevacizumab 400mg - antineoplastic agents

Canada - English - Health Canada

biosimilar collaborations ireland limited - bevacizumab - solution - 100mg - bevacizumab 100mg - antineoplastic agents

Canada - English - Health Canada

biosimilar collaborations ireland limited - adalimumab - solution - 20mg - adalimumab 20mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

biosimilar collaborations ireland limited - adalimumab - solution - 40mg - adalimumab 40mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

biosimilar collaborations ireland limited - adalimumab - solution - 40mg - adalimumab 40mg - disease-modifying antirheumatic agents