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Category Archives: Biosimilars

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International Council on Harmonisation (ICH) Includes Generic and Biosimilars Trade Organization (IGBA) for the First Time

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs

ThinkstockPhotos-179040440On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH as an Assembly Member.  For the first time, an association representing … Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 2 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaThis is a continuation of coverage of the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) joint 19th IGBA Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 1 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaOn June 8-10, 2016, the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) held a joint 19th IGBA Continue Reading

Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for Previously-Approved Biological Product Names Published

Posted in Biological Products, Biosimilars, Guidance

ThinkstockPhotos-457742249On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products – both those previously approved and those … Continue Reading

Biomanufacturing Technology Summit 2015 in Maryland: Bioanalytics Guiding Quality, Where Increased Collaboration Could Lead to Faster and Greater Discoveries

Posted in Biological Products, Biosimilars, Meetings

ThinkstockPhotos-188078261On June 25, 2015, the Institute for Bioscience and Biotechnology Research (IBBR), the National Institute of Standards and Technology (NIST), and the University of Maryland (UM) put on its second Biomanufacturing Technology Summit, “Manufacturing Science Analytics: Predictors of Biotherapeutic Product … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

Posted in Biosimilars, Clinical Studies, Drugs, European Union, Generic Drugs, Litigation, Meetings, Rare Diseases

EGA Legal Affairs ForumOn the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates and strategies (see here for a … Continue Reading

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part One of Two

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (“EGA”) held its 11th Annual Legal Affairs Forum. The Forum kicked off with an introduction by Sergio Napolitano, Legal Affairs and Trade Director, EGA, who organized this … Continue Reading

EGA’s 11th Legal Affairs Forum in Brussels Later This Week: Still Time to Register!

Posted in Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Legislation, Litigation

EGA Legal Affairs ForumLater this week in Brussels, Belgium, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum. The Forum will be held on March 26-27, 2015 utilizing an interactive format that provides ample opportunities … Continue Reading

11th Legal Affairs Forum in Brussels, Belgium on March 26-27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Litigation, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum in Brussels, Belgium. The Forum will focus particularly on:

–       EGA 2020: Where Are the Latest Trends Leading this Sector?

A … Continue Reading

McGuireWoods’ Brian Malkin Speaks on Biosimilars Patent Litigation at EGA’s Legal Affairs Forum in Brussels on March 27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Meetings

EU buildingOn March 27, 2015, McGuireWoods’ Brian J. Malkin will be speaking on “Biosimilars Patent Litigation” at the European Generic Medicines Association’s (EGA’s) Legal Affairs Forum in Brussels, Belgium. The Legal Affairs Forum highlights trends in the generic sector leading to … Continue Reading

FDA/CMS Summit Demonstrates Increasing Importance for Parallel Review Considerations and Ongoing FDA and CMS Reform – Part 2 of 2

Posted in Biological Products, Biosimilars, Drugs, Healthcare, Medicare, Meetings, Reimbursement

On December 11-12, 2014, Informa Business Information, Inc. presented its 10th Annual FDA/CMS Summit.  The Summit delivered presentations from key leaders in both the FDA and Centers for Medicare and Medicaid (CMS) sectors with many thought-provoking discussions.  Some of those Continue Reading