The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a mutual recognition agreement (MRA) regarding good manufacturing practice (GMP) inspections in the European Union. Slovakia was the last of the 28 member states of the European Union to be recognized as capable of
EMA
How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.
- FDA approves the fourth Herceptin® (trastuzumab) biosimilar—no trastuzumab biosimilar has launched in the United States to date.
- European Medicines Agency approves ninth and tenth adalimumab biosimilars and second bevacizumab biosimilar.
As pharmaceutical drug costs attract increasing media attention…
FDA’s Biosimilar Approvals Accelerate in 2018: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States.
- Pfizer launches Retacrit®, an epoetin alfa biosimilar, in the United States.
- FDA approves the first rituximab biosimilar, although it has not yet launched in the United States.
- European Medicines Agency approves third, fourth, and fifth pegfilgrastim biosimilars and a fifth trastuzumab biosimilar, while
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How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar
- Pfizer launches NivestymTM, a filgrastim biosimilar, in the United States
- Only five of twelve approved biosimilars have launched in the United States
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set…
How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)
- European Medicines Agency approves third and fourth trastuzumab, fourth infliximab, and fifth, sixth and seventh adalimumab biosimilars
- Only four of twelve approved biosimilars have launched in the United States
As pharmaceutical drug costs attract increasing media attention and political scrutiny,…
U.S. FDA Approves First Biosimilar to Neulasta
Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was developed by Amgen and first approved in the U.S. and Europe in 2002. Following the approval announced on June 4, 2018, Fulphila, which was co-developed with Biocon, becomes the first biosimilar to pegfilgrastim approved in the U.S.
The…
How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars
- FDA has not approved any biosimilar drug in 2018
- Only three of nine approved biosimilars have launched in the United States
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S.…
Fujifilm and Mylan Announce Partnership to Commercialize Adalimumab Biosimilar
Fujifilm Kyowa Kirin Biologics Co., Ltd. (“Fujifilm”) recently announced that it will partner with Mylan N.V. (“Mylan”) to commercialize a biosimilar to adalimumab developed by Fujifilm. Under the terms of the agreement, Fujifilm grants Mylan an exclusive license to commercialize the biosimilar in Europe, and will receive an up-front fee in return. In addition, Fujifilm…
Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars
- U.S. Food & Drug Administration approves a second infliximab biosimilar
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years. Global sales…
Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- European Medicines Agency newly approves two adalimumab biosimilars
- U.S. Food & Drug Administration approves first bevacizumab biosimilar
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years. Global sales for the top nine branded biologic…