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PharmaShots Year in Review: Biosimilars Approvals in 2018

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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

3.  Sandoz's Hymiroz (adalimumab-adaz, biosimilar) Receives the US FDA Approval for
Treatment of Chronic Autoimmune Diseases

Published: 31 Oct, 2018  | Tags: Sandoz, Hymiroz, (adalimumab-adaz), Receives, the US FDA, Approval, Treatment, Chronic, Autoimmune Diseases

4.  Coherus Udenyca (pegfilgrastim-cbqv, biosimilar) Receives FDA Approval for Patients
Receiving Myelosuppressive Chemotherapy

Published: 02 Nov, 2018  | Tags: Coherus, Udenyca, (pegfilgrastim-cbqv), Receives, the US FDA, Approval, Patients, Receiving, Myelosuppressive, Chemotherapy

5.  Celltrion's Truxima (rituximab-abbs, biosimilar) Receives FDA Approval for Three
on-Hodgkin's Lymphoma Indications

Published: 25 Nov, 2018  | Tags: Celltrion, Truxima, rituximab-abbs, Receives, FDA, Approval, Three on-Hodgkin's Lymphoma, Indications, mAb

6.  Celltrion and Teva's Herzuma (trastuzumab-pkrb, biosimilar, Herceptin) Receives FDA Approval
for HER2-Overexpressing Breast Cancer

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

2.    Celltrion's Herzuma (trastuzumab, biosimilar, CT-P6) Receives EMA Approval for Breast
Cancer, Metastatic Breast Cancer and Metastatic Gastric Cancer

Published: 14 Feb, 2018 | Tags: Celltrion, Herzuma, (Trastuzumab
Biosimilar, CT-P6), Receives, EMA, Approval, Breast Cancer, Metastatic Breast
Cancer, Metastatic Gastric Cancer

3.  Amgen and Allergan's ABP 980 (trastuzumab, biosimilar) Receives CHMP Recommendation
for Three Types of Cancer

Published: 23 Mar, 2018 | Tags: Amgen, Allergan, ABP 980, (biosimilar, Herceptin), Receives, CHMP, Recommendation, Three, Types, Cancer

4.  Sandoz's Zessly (infliximab, biosimilar) Receives EU Approval for Gastroenterological,
Rheumatological And Dermatological Diseases

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

6. Coherus Biosciences  Udenyca (pegfilgrastim, biosimilar) Receives EU Marketing Approval
for Febrile Neutropenia

Published: 25 Sept, 2018 | Tags: Coherus Biosciences, EU, Febrile Neutropenia, Marketing, Approval, Pegfilgrastim, Biosimilar, Regulatory, Udenyca

7.   Mylan & Biocon Receives CHMP (EMA) Recommendation to Ogivri (trastuzumab,
biosimilar) for HER-2 Breast Cancer

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 Neutropeni
a

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

11. Mylan and Biocon's Semglee (insulin glargine, biosimilar) Receives EU Approval for
Patients with Diabetes

Published:26 Nov, 2018 | Tags: Mylan, Biocon, Semglee, Receives, EU, Approval, Patients, Diabetes

 

12.Sandoz's Ziextenzo (pegfilgrastim, biosimilar) Receives EU Approval for Reduction in
Duration of Neutropenia

Published: 27 Nov, 2018| Tags: Sandoz's, Ziextenzo, (pegfilgrastim), Receives, EU, Approval, Reduction, Duration, Neutropenia, Eighth, Approval, Febrile Neutropenia

 


Senior Editor

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

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