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- USPTO and DOJ Statement of Interest in Collision Communications: Another Thumb on the Scale in Favor of NPE Patent Plaintiffs
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Category: Biosimilars
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By Donald Zuhn — President Obama Wants to Speed Up Introduction of Generic Drugs In a health care town hall meeting held in Portsmouth, NH last week, President Obama told attendees that he wanted to speed up the introduction of generic drugs into the marketplace. His comment came during an exchange with a man…
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By Donald Zuhn — Last week, CNBC anchor Joe Kernen challenged Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood over the wisdom of implementing a follow-on biologics (FOB) regulatory pathway that provides innovator biologics manufacturers with 12 years of exclusivity. Mr. Greenwood, however, was up to the challenge, as he explained why a…
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By Donald Zuhn — California Healthcare Institute Applauds Eshoo-Inslee-Barton Amendment Last Friday, the House Committee on Energy and Commerce passed a health care reform bill by a close 31-28 vote (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period"). One of the mark-ups to the bill was an amendment offered…
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By Kevin E. Noonan — The most troublesome point of contention in the follow-in biologics (FOBs) debate has undoubtedly revolved around the term for data exclusivity. In a subject so complex, it may be understandable that there are differing views about the importance of data exclusivity, and whether this is "much ado about nothing"…
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By Donald Zuhn — On Friday, the House Committee on Energy and Commerce approved a health care reform bill by a narrow three-vote margin (31-28). The bill (H.R. 3200), entitled "America's Affordable Health Choices Act," was originally introduced in the House on July 14, 2009 by Rep. John Dingell (D-MI). According to a statement…
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By Donald Zuhn — BIO CEO Cites Letters from Patient Groups Supporting Longer Exclusivity Period Last week, BIO President and CEO Jim Greenwood (at right) noted that a number of patient groups had joined BIO in seeking passage of a follow-on biologics bill providing a minimum of 12 years of data exclusivity. Mr. Greenwood…
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By Donald Zuhn — Virginia Governor: Time Has Come to Move Forward Virginia Governor Timothy Kaine, once a candidate to be President Obama's running mate, sent a letter to the Virginia Congressional delegation at the end of June, stating that he was "encouraged by efforts in Congress to strengthen the approval process for biogeneric…
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By Donald Zuhn — In a hearing on follow-on biologics held earlier this week, the House Subcommittee on the Courts and Competition Policy heard testimony from seven witnesses including Rep. Anna Eshoo (D-CA), economist Alex Brill, Momenta Pharmaceuticals General Counsel Bruce Leicher, and representatives from the National Venture Capital Association (NVCA), Biotechnology Industry Organization…
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By Kevin E. Noonan — Follow-on biologic drugs, or biosimilars as they are called in Europe, are once again the subject of attempts by Congress to provide a regulatory pathway for approval. Currently, these drugs are not regulated by the Food, Drug and Cosmetic Act and hence not subject to the provisions of the…
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By Donald Zuhn — This afternoon, the House Subcommittee on the Courts and Competition Policy held a hearing on follow-on biologics entitled "Biologics and Biosimilars: Balancing Incentives for Innovation." Among the witnesses appearing before the Subcommittee were Rep. Anna Eshoo (D-CA), who introduced follow-on biologics legislation (H.R. 1548) in the House that would provide…
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