Biosimilars Ahead, Proceed with Caution
By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday,...
View ArticleData Exclusivity Protects Innovators and Assures Investors
Biotechnology companies must have some certainty that they can protect their investment in the development of new breakthrough therapies for a substantial period of time. This protection helps...
View ArticleCalifornia Continues Responsible Support for Interchangeability of Biologic...
Yesterday, California’s State Assembly Committee on Appropriations took another decisive step when they unanimously voted in support of the revised SB 598 by recommending it back to the full Assembly...
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State Legislation Needed For Substitution of Interchangeable Biologics
A great deal of the media coverage relating to California’s Senate Bill 598 neglects to mention a key issue in the biosimilars debate. This bill – or legislation similar to it – is essential to allow...
View ArticleWashington Gov. Jay Inslee to Keynote BIO Convention in China
Next month, BIO will be hosting our 3rd Annual BIO Convention in China, November 11-13. We are very pleased that Washington Governor Jay Inslee will be joining us as our keynote speaker on November 12....
View ArticleBIO Responds to GPhA Citizen Petition on Biosimilars Naming
Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all...
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FDA Week: For Biologics, A Name Isn’t Just A Name (Jim Greenwood op-ed)
What is in a name? Names help make medicinal products more easily distinguishable by doctors, pharmacists and patients. When you are talking about biologics, complex medicines that are manufactured...
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Indiana Governor Signs Bill that Supports Transparent Communication
Indiana Governor Mike Pence has signed bipartisan legislation enabling retail pharmacies within his state to substitute interchangeable biologic medicines, once approved, for the innovator drug on...
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BIO Recognizes the Work of Two Indiana Legislators
Across the country state lawmakers are addressing the issue of biosimilars, lower-cost biologic medicines that stand to benefit severely ill patients combating complex and life threatening diseases....
View ArticleEnsuring the Safety and Commercial Success of Biosimilars in the United States
The forthcoming arrival of biosimilars into the U.S has spurred debate over the approaches that the FDA and industry should take to ensure patient safety while promoting market competition and...
View ArticleDocs to FDA: Biosimilars should have different names than branded drugs
Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have...
View ArticlePitts Sounds off on Biosimilar Naming
This week, the Food and Drug Law Institute published a white paper – Biosimilar Nomenclature: Can we achieve the truth, the whole truth, & nothing but the truth? – outlining key considerations...
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Updated Legal and Regulatory Frameworks Needed for Biosimilars
Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. We call on the FDA to release final guidance on processes and scientific criteria...
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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?
In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products. But it was not...
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FDA Acts on Biosimilars
The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be...
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WSJ: U.S. Concessions on TPP Means Fewer Cures
Today’s Wall Street Journal editorial, Pacific Trade Brinksmanship, does an outstanding job highlighting the important role that patent protection plays in promoting innovation and fostering medical...
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Registration for BIO’s Spring IP Counsels Committee Conference is now OPEN!
Tired of those pea-coats and earmuffs? Wish you were lying on a beach right now, potentially with some interesting literature on developments in the biotech patent space? Do we have good news for YOU....
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#BIO2017: What’s Happening in the World of IP?
Who’s ready to hit the beach? Wait, did I say beach? I meant the San Diego Convention Center. ….But the beach will be waiting for you once you wrap up two and a half days of IP educational programming!...
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