PharmaShots Year in Review: Biosimilars Approvals in 2018
THE US FDA APPROVALS
1. Pfizer's Retacrit (epoetin alfa-epbx, biosimilar) Receives FDA Approval for Anemia
Published: 15 May, 2018 | Tags: Pfizer, Retacrit, epoetinalfa-epbx, biosimilar, Receives, FDA, Approval, Anemia
2. Pfizer's Nivestym (filgrastim-aafi, biosmilar) Receives FDA Approval for
Neutropenia
Published: 20 Jul, 2018 | Tags: (filgrastim-aafi approval biosmilar), Neutropenia, Nivestym, Pfizer, Receives, the US FDA
Published: 31 Oct, 2018 | Tags: Sandoz, Hymiroz, (adalimumab-adaz), Receives, the US FDA, Approval, Treatment, Chronic, Autoimmune Diseases
Published: 02 Nov, 2018 | Tags: Coherus, Udenyca, (pegfilgrastim-cbqv), Receives, the US FDA, Approval, Patients, Receiving, Myelosuppressive, Chemotherapy
Published: 25 Nov, 2018 | Tags: Celltrion, Truxima, rituximab-abbs, Receives, FDA, Approval, Three on-Hodgkin's Lymphoma, Indications, mAb
Published: 14 Dec, 2018 | Tags: Celltrion, Teva, Herzuma, trastuzumab-pkrb, Biosimilar, Herceptin, (trastuzumab), Receives, FDA, Approval, HER2-Overexpressing, Breast Cancer
EU APPROVALS
1. Amgen and Allergan's Mvasi (bevacizumab, biosimilar) + Combination Therapy Receives EU's MAA Approval for Treatment of Certain Types of Cancer
Published: 18 Jan, 2018 | Tags: Mvasi, (bevacizumab, biosimilar), Combination Therapy, Receives, EU, MAA, Approval, Treatment, Certain Types, Cancer
Published: 14 Feb, 2018 | Tags: Celltrion, Herzuma, (Trastuzumab
Biosimilar, CT-P6), Receives, EMA, Approval, Breast Cancer, Metastatic Breast
Cancer, Metastatic Gastric Cancer
Published: 23 Mar, 2018 | Tags: Amgen, Allergan, ABP 980, (biosimilar, Herceptin), Receives, CHMP, Recommendation, Three, Types, Cancer
Published:24 May, 2018 | Tags: Sandoz, Zessly, (infliximab), Receives, EU, Approval, Gastroenterological, Rheumatological, Dermatological, Diseases
5. Sandoz's Hyrimoz (adalimumab, biosimilar)Receives EU Approval for Autoimmune Disorders
Published: 27 Jul, 2018 | Tags: Sandoz, Hyrimoz, adalimumab, Receives, EU, Approval, Autoimmune, Disorders
Published: 25 Sept, 2018 | Tags: Coherus Biosciences, EU, Febrile Neutropenia, Marketing, Approval, Pegfilgrastim, Biosimilar, Regulatory, Udenyca
Published: 19 Oct, 2018 | Tags: Mylan, Biocon, Receives, CHMP, Recommendation, Ogivri (trastuzumab, biosimilar), HER-2 B
8. Mylan's Hulio (adalimumab, biosimilar) Receives EU Approval for Autoimmune Diseases
Published: 19 Oct, 2018 | Tags: Mylan, Hulio, (adalimumab, biosimilar), Receives, EU, Approval, Autoimmune Diseases
9. Biocon and Mylan's Fulphila (pegfilgrastim, biosimilar) Receives CHMP (EMA)
Recommendation for Neutropenia
Published: 21 Nov, 2018 | Tags: Biocon, Mylan, Fulphila, (pegfilgrastim, Neulasta biosimilar), Receives, CHMP, (EMA), Recommendation, Neutropenia
10. Mundipharma Receives EU Approval for Pelmeg (pegfilgrastim, biosimilar)
Published: 24 Nov, 2018 | Tags: Mundipharma, Receives, EU approval, Pelmeg, Biosimilar, Neutropenia, Febrile neutropenia Cytotoxic CT, Malignancy, Neulasta, G-CSF, CHMP
Published:26 Nov, 2018 | Tags: Mylan, Biocon, Semglee, Receives, EU, Approval, Patients, Diabetes
Published: 27 Nov, 2018| Tags: Sandoz's, Ziextenzo, (pegfilgrastim), Receives, EU, Approval, Reduction, Duration, Neutropenia, Eighth, Approval, Febrile Neutropenia
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com