biosimilars

FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations
FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations
RAPS.org
FDA
biosimilars
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Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability
Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability
FDA Law Blog
FDA
biosimilars
interchangeability
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AbbVie stock up 1.3% after announcing resolution to litigation over Humira in the U.S.
AbbVie stock up 1.3% after announcing resolution to litigation over Humira in the U.S.
Marketwatch
AbbVie
biosimilars
Humira
patents
Boehringer Ingelheim
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Interchangeable Insulins: FDA Holds Public Meeting
Interchangeable Insulins: FDA Holds Public Meeting
RAPS.org
diabetes
insulin
biosimilars
FDA
biosimilar insulin
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House Unanimously Passes Bills Updating FDA’s Orange and Purple Books
House Unanimously Passes Bills Updating FDA’s Orange and Purple Books
RAPS.org
Orange Book
generics
Purple Book
biosimilars
FDA
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Pfizer Calls for Compromise on Retroactively Using Suffixes in Biologic Names
Pfizer Calls for Compromise on Retroactively Using Suffixes in Biologic Names
RAPS.org
Pfizer
FDA
suffixes
drug names
biologics
biosimilars
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House Judiciary Committee Advances Four Bills Targeted at Generic Competition
House Judiciary Committee Advances Four Bills Targeted at Generic Competition
RAPS.org
generics
CREATES Act
biosimilars
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FDA Approves 19th Biosimilar, 2nd for Enbrel
FDA Approves 19th Biosimilar, 2nd for Enbrel
RAPS.org
FDA
Samsung Bioepis
Eticovo
biosimilars
Amgen
Enbrel
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Say goodbye to AbbVie's ever-growing Humira sales: The biosim decline has officially begun
Say goodbye to AbbVie's ever-growing Humira sales: The biosim decline has officially begun
Fierce Pharma
AbbVie
Humira
biosimilars
earnings
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Gottlieb, biosimilars companies and consultants reject price control proposal
Gottlieb, biosimilars companies and consultants reject price control proposal
BioCentury
biosimilars
drug pricing
FDA
Scott Gottlieb
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Biopharma CEOs Explain Problems With Biosimilars to Congress
Biopharma CEOs Explain Problems With Biosimilars to Congress
RAPS.org
biosimilars
Pharma CEOs
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Generics would get a new boost from bipartisan bills
Generics would get a new boost from bipartisan bills
BioCentury
Senate
generics
biosimilars
competition
legislation
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Coherus' Neulasta biosimilar surprises with strong early uptake
Coherus' Neulasta biosimilar surprises with strong early uptake
Biopharma Dive
Coherus Biosciences
Neulasta
biosimilars
Udenyca
Amgen
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Sandoz resubmission puts Amgen's Neulasta at further risk of competition
Sandoz resubmission puts Amgen's Neulasta at further risk of competition
Biopharma Dive
FDA
Novartis
biosimilars
Sandoz
Amgen
Neulasta
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AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report
AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report
Fierce Pharma
AbbVie
Humira
biosimilars
drug pricing
Europe
Netherlands
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Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars
Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars
RAPS.org
EMA
Europe
biosimilars
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DOJ supports ruling to strike down ACA, including biosimilars provisions
DOJ supports ruling to strike down ACA, including biosimilars provisions
BioCentury
biosimilars
Affordable Care Act
Donald Trump
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Roche clinches EU approval for MabThera in rare autoimmune indication — will it boost dwindling sales amid biosimiar competition?
Roche clinches EU approval for MabThera in rare autoimmune indication — will it boost dwindling sales amid biosimiar competition?
Endpoints
Roche
MabThera
Rituxan
Europe
biosimilars
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CEO of Novartis’ generics unit quits, sparking sale speculation
CEO of Novartis’ generics unit quits, sparking sale speculation
Pharmaforum
Novartis
Sandoz
generics
M&A
Richard Francis
biosimilars
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Amgen's top-selling Enbrel in balance as key court ruling nears
Amgen's top-selling Enbrel in balance as key court ruling nears
Biopharma Dive
Amgen
patents
Enbrel
biosimilars
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