Terrapinn is organizing the World Biosimilar Congress – Europe in London, UK on 11-13 September 2012.
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News/Headlines
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Meaningful finger-print-like analysis of biologics by Array Bridge
Array Bridge Inc. has developed a Protein Conformation Array (PCA) kit for three dimensional structural...
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GPhA underscores commitment to providing consumers timely access to safe and effective biosimilars
The Generic Pharmaceutical Association (GPhA) last week reiterated its commitment to safeguarding...
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Alliance for Safe Biologic Medicines urge FDA to ensure that patient safety is the cornerstone of biosimilar pathway
Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines outlined five areas...
- BIO presentation at FDA public meeting on biosimilars
- Datamonitor releases a new report – “Biosimilars: Regulatory Update”
- High expectations for new U.S. biosimilar pharmaceuticals following FDA guidance documents
Events
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World Drug Repositioning Congress Europe
Terrapinn is organizing the World Drug Repositioning Congress – Europe in London, UK on...
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World Biosimilar Congress Europe
Terrapinn is organizing the World Biosimilar Congress – Europe in London, UK on 11-13 September...
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Regulatory Strategies – The Pathway Forward in the EU, US and the Rest of the World
Speid & Associates, Inc. is organizing the third WEBEX in a series of WEBEX’s focused on...
- Life Science Legal & Business Strategy Conference
- Emerging trends in biopharmaceutical manufacturing webinar
- Biosimilars – Understanding Regulatory Challenges Course
Guidelines
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New Biologics and Biocomparables Guidelines are effective in Mexico
In Mexico, new guidelines became effective in April for the marketing authorization of biologics...
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EMA publishes new document on regulatory procedural advice on biosimilars
The European Medicines Agency has published a new document on regulatory procedural advice on...
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FDA draft guidance on biosimilar product development
The U.S. Food and Drug Administration issued three draft guidance documents on biosimilar product...
Policies
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GPhA underscores commitment to providing consumers timely access to safe and effective biosimilars
The Generic Pharmaceutical Association (GPhA) last week reiterated its commitment to safeguarding...
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BIO presentation at FDA public meeting on biosimilars
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration...
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Sandoz testimony at FDA hearing on biosimilars will emphasize need for consistent regulatory standards
Sandoz announced today that Dr. Mark McCamish, Head of Global Biopharmaceutical Development, will...
- Biosimilar stakeholder comments for FDA guidelines
- Hong Kong needs to formulate regulations for biosimilars
- EMA publishes new document on regulatory procedural advice on biosimilars
Research/Analysis
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Datamonitor releases a new report – “Biosimilars: Regulatory Update”
Datamonitor is an international company providing market intelligence, data analysis and opinion...
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RNCOS releases a new report – G-CSF biosimilars market forecast to 2015
RNCOS, is an Indian research company established in 2002. The company provides actionable insights...
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A biosimilar manufacturer: BioXpress Therapeutics SA
Located in Geneva, Switzerland, BioXpress Therapeutics SA is a provider of high-quality biologic...
- New visiongain report about biosimilars market
- Biosimilars: The Way Forward In the United States
- A biosimilar manufacturer: Pfenex
Latest Posts on Biosimilar News
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Events Upcoming Events
World Drug Repositioning Congress Europe
Terrapinn is organizing the World Drug Repositioning Congress – Europe in London, UK on 11-13 September 2012.
Read more → -
Events Featured Upcoming Events
World Biosimilar Congress Europe
Terrapinn is organizing the World Biosimilar Congress – Europe in London, UK on 11-13 September 2012.
Read more → -
Events Upcoming Events
Regulatory Strategies – The Pathway Forward in the EU, US and the Rest of the World
Speid & Associates, Inc. is organizing the third WEBEX in a series of WEBEX’s focused on the strategic development of biosimilars.
Read more → -
News/Headlines
Meaningful finger-print-like analysis of biologics by Array Bridge
Array Bridge Inc. has developed a Protein Conformation Array (PCA) kit for three dimensional structural comparability analysis of Biologics and Biosimilars.
Read more → -
Events Upcoming Events
Life Science Legal & Business Strategy Conference
Global Technology Community is organizing the Life Science Legal & Business Strategy Conference in San Diego, California on June 7-8, 2012.
Read more → -
News/Headlines Policies
GPhA underscores commitment to providing consumers timely access to safe and effective biosimilars
The Generic Pharmaceutical Association (GPhA) last week reiterated its commitment to safeguarding the intent of the Biologics Price Competition and Innovation Act (BPCIA) and ensuring that patients have timely access to safe, effective and affordable biosimilar medications.
Read more → -
Events Upcoming Events
Emerging trends in biopharmaceutical manufacturing webinar
Report Linker is organizing a free webinar about the Emerging Trends in Biopharmaceutical Manufacturing.
Read more → -
News/Headlines
Alliance for Safe Biologic Medicines urge FDA to ensure that patient safety is the cornerstone of biosimilar pathway
Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines outlined five areas of concern that the U.S. FDA should resolve before they allow biosimilar medications on the U.S. drug market in prepared testimony for the FDA’s May 11th public hearing.
Read more →
