Betting on Biologics
Richmond.com
May 13, 2008
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MHRA Gives Green Light to Study of Insmed FOB
FDA News
April 30, 2008
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Panel Debates Knotty Challenges Facing Follow-on Biologics
BioWorld
April 29, 2008
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Buckets Of Money: Biosimilars & Billions Of Dollars
Pharmalot
April 24, 2008
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Big Pharma May Be Big Player in Follow-On Biologics Market
The RPM Report
April, 2008
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Surprise Players in Follow-On Biologics?
In Vivo
April 23, 2008
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Drugs Cost Far More Than They Should
Milwaukee Journal Sentinel
April 19, 2008
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Insmed to Initiate Phase I Study of Follow-on Biologic Drug
Pharmaceutical Business Review
April 17, 2008
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Insmed Advances to Clinic with First Follow-On Biologic, INS-19
BioWorld
April 17, 2008
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MHRA Gives Green Light to Study of Insmed FOB
FDA News
April 17, 2008
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House Subcommittee Seeks Consensus on Follow-On Biologics
FDA News
April 16, 2008
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When Drug Costs Soar Beyond Reach
New York Times
April 15, 2008
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House Committee Asks Industry for Input on FDA Approval Process of Follow-On Biologics
Kaiser Daily Health Policy Report
April 9, 2008
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Pallone, Deal Reach Out on Crafting Biologic Legislation
Congress Daily
April 9, 2008
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Competition in Biotech Can Bring Costs Down
Richmond Times-Dispatch
April 6, 2008
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Potential Federal Drug Savings Could Propel Biosimilars Bill
FDA Legislative Watch
April 1, 2008
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Spend Less? Congress May Like Biosimilars
Pharmalot
April 1, 2008
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Momenta, Insmed May Gain From Biotech Generics Law
Bloomberg
March 27, 2008
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Europeans Lead With Biosimilars
Pharmacy Times
March 26, 2008
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Patent Expirations Could Mean Biologics Competition
Pharmacy Times
March 25, 2008
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When a Drug Costs $300,000
New York Times
March 23, 2008
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More Groups Demand Pathway For Biogenerics
Drug Topics News
March 24, 2008
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Health Canada Publishes Draft Biosimilar Guidance
FDA News
March 24, 2008
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Is Competition Coming? Interview with Insmed CEO Geoffrey Allan
The American
March 21, 2008
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Medicare Report Makes Case for Biosimilars
FDA News
March 17, 2008
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Lawmakers Submit New Biosimilar Proposal
Drug Industry Daily
March 17, 2008
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Biogenerics Conference Addresses Scientific and Regulatory Issues Surrounding Biosimilars
BioPharm Bulletin
March 12, 2008
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Report to the Congress: Medicare Payment Policy
MedPAC
March, 2008
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Biologics build lobbying army for '09
Politico
March 11, 2008
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GPhA sets sights on increasing access to generic medicines in 2008
Drug Topics
March 10, 2008
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Cost-control plan: generics
Boston Globe
March 3, 2008
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Biogenerics could save US$378 billion
Generics Bulletin
March 1, 2008
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Battleground marked out in US biogenerics debate
Generics Bulletin
March 1, 2008
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Orphaning Biotech? The Impact of Biosimilars on Biotech Investment
In Vivo
February, 2008
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Generics -- and Biogenerics -- Are the Solution to Reducing Rising Health Care Costs, Says GPhA
Generic Pharmaceutical Association
February 26, 2008
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Scientific and Legal Viability of Follow-on Protein Drugs
New England Journal of Medicine
February 21, 2008
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Biotech Firm Sets Sights on Biosimilars
FDA News
February 20, 2008
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HHS: FDA, Lawmakers Should Collaborate on Biosimilar Proposal
FDA News
February 20, 2008
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PBMs, Purchasers Pushing Generic Initiatives
FDA News
February 20, 2008
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New Report Identifies $378 Billion in Savings From Generic Biologics
Biotech IP Blog
February 20, 2008
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Dr. Robert Shapiro Discusses Follow-on Biologics Report
Patent Docs Blog
February 19, 2008
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Can Approval of Biogenerics Really Save Money?
Patent Baristas Blog
February 19, 2008
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Biotech pushes for generics bill in 2008
Associated Press
February 14, 2008
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Bush plan would allow generic biotech drugs
Chicago Tribune
February 14, 2008
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Insmed Announces National Awareness Campaign Regarding Follow-on Biologics
PatentDocs Blog
February 13, 2008
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FDA, Congress to Jointly Form Follow-on Biologics Proposal
BioWorld Today
February 8, 2008
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ABOUT FACE: BUSH, BIOTECH FIRMS SEEK BIOSIMILARS AS GENERICS STALL
Inside Health Policy
February 8, 2008
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Insmed education effort targets Congress, public
PR WEEK
8 February 2008
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Insmed applauds US biosimilars moves
Pharma Marketletter
7 February 2008
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Lawmakers Push for Biosimilar Legislation in New Healthcare Initiative
FDA News
February 7, 2008
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Generic Drug Makers, Prescription Drug Firms Well-Positioned in Light of Election Uncertainty
AP
February 6, 2008
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President's Request Would Give FDA $2.4 Billion in Fiscal 2009
FDA News
February 6, 2008
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FDA $2.4B Budget Includes Follow-On Biologic Pathway
BioWorld Magazine
February 6, 2008
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Insmed Takes Follow-On Biologics Push to the Web
The Pink Sheet Daily
February 5, 2008
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Generic Pharmaceutical Association Releases Statement on FDA FY09 Budget
Generic Pharmaceutical Association
February 5, 2008
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White House recognizes the importance of establishing a follow-on biologics approval pathway
Reuters
February 5, 2008
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Lawmakers Push for Biosimilar Legislation in New Healthcare Initiative
FDA News
February 1, 2008
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New lobbying strategy: Stall?
Politico
February 1, 2008
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Congress, FDA need to free up path to generic biologics
St. Louis Post-Dispatch
January 9, 2008
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Biotech as Bush bows out, Nature Biotechnology
Nature
January 1, 2008
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Path may clear for biotech generics
Chicago Tribune
December 26, 2007
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The U.S. Senate and House of Representatives are both considering legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on biologics.
In December of 2007, the House Committee on Energy and Commerce Subcommittee on Health asked its Members to submit questions to be responded to by various stakeholders regarding follow-on biologics legislation.
--Check this page for future updates on the establishment of a follow-on biologics approval pathway.--
