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 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

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