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biosimilars
FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations
RAPS.org
Tue, 05/21/19 - 11:03 pm
FDA
biosimilars
Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability
FDA Law Blog
Thu, 05/16/19 - 10:28 am
FDA
biosimilars
interchangeability
AbbVie stock up 1.3% after announcing resolution to litigation over Humira in the U.S.
Marketwatch
Tue, 05/14/19 - 09:31 am
AbbVie
biosimilars
Humira
patents
Boehringer Ingelheim
Interchangeable Insulins: FDA Holds Public Meeting
RAPS.org
Mon, 05/13/19 - 08:13 pm
diabetes
insulin
biosimilars
FDA
biosimilar insulin
House Unanimously Passes Bills Updating FDA’s Orange and Purple Books
RAPS.org
Wed, 05/8/19 - 05:21 pm
Orange Book
generics
Purple Book
biosimilars
FDA
Pfizer Calls for Compromise on Retroactively Using Suffixes in Biologic Names
RAPS.org
Tue, 05/7/19 - 06:47 pm
Pfizer
FDA
suffixes
drug names
biologics
biosimilars
House Judiciary Committee Advances Four Bills Targeted at Generic Competition
RAPS.org
Tue, 04/30/19 - 05:33 pm
generics
CREATES Act
biosimilars
FDA Approves 19th Biosimilar, 2nd for Enbrel
RAPS.org
Fri, 04/26/19 - 07:38 pm
FDA
Samsung Bioepis
Eticovo
biosimilars
Amgen
Enbrel
Say goodbye to AbbVie's ever-growing Humira sales: The biosim decline has officially begun
Fierce Pharma
Thu, 04/25/19 - 07:16 pm
AbbVie
Humira
biosimilars
earnings
Gottlieb, biosimilars companies and consultants reject price control proposal
BioCentury
Mon, 04/15/19 - 11:33 pm
biosimilars
drug pricing
FDA
Scott Gottlieb
Biopharma CEOs Explain Problems With Biosimilars to Congress
RAPS.org
Sat, 04/13/19 - 12:15 pm
biosimilars
Pharma CEOs
Generics would get a new boost from bipartisan bills
BioCentury
Sat, 04/13/19 - 12:04 pm
Senate
generics
biosimilars
competition
legislation
Coherus' Neulasta biosimilar surprises with strong early uptake
Biopharma Dive
Mon, 04/8/19 - 05:44 pm
Coherus Biosciences
Neulasta
biosimilars
Udenyca
Amgen
Sandoz resubmission puts Amgen's Neulasta at further risk of competition
Biopharma Dive
Wed, 04/3/19 - 09:31 pm
FDA
Novartis
biosimilars
Sandoz
Amgen
Neulasta
AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report
Fierce Pharma
Tue, 04/2/19 - 12:09 pm
AbbVie
Humira
biosimilars
drug pricing
Europe
Netherlands
Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars
RAPS.org
Thu, 03/28/19 - 07:45 pm
EMA
Europe
biosimilars
DOJ supports ruling to strike down ACA, including biosimilars provisions
BioCentury
Tue, 03/26/19 - 12:20 pm
biosimilars
Affordable Care Act
Donald Trump
Roche clinches EU approval for MabThera in rare autoimmune indication — will it boost dwindling sales amid biosimiar competition?
Endpoints
Fri, 03/15/19 - 09:30 am
Roche
MabThera
Rituxan
Europe
biosimilars
CEO of Novartis’ generics unit quits, sparking sale speculation
Pharmaforum
Thu, 03/14/19 - 10:06 am
Novartis
Sandoz
generics
M&A
Richard Francis
biosimilars
Amgen's top-selling Enbrel in balance as key court ruling nears
Biopharma Dive
Wed, 03/13/19 - 04:32 pm
Amgen
patents
Enbrel
biosimilars
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