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Category: Biosimilars
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Guest Post by Prof. Christopher M. Holman, UMKC School of Law Much of the current discussion surrounding the proposed follow-on biologics bills assumes that a “statutory path” is necessary before FDA can implement an abbreviated biologics license application (BLA) process for biotechnology-derived therapeutic proteins. In fact, FDA probably already has the authority…
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On Wednesday, May 2nd, two subcommittees of the House Committee on Energy and Commerce will hold hearings of importance to pharmaceutical companies: first, on legislation to establish an abbreviated pathway for FDA approval of follow-on biologics; second, on a pending bill to ban “reverse payment” settlements of Hatch-Waxman litigation. At 10 a.m. ET, the Subcommittee…
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A number of interesting news reports concerning follow-on biologics have been published in recent days: “Hopes for Speedy Action on Generic Biologics Fade in Senate“–Biologic Drug Report 4/16/07 “Lobbyists Take Aim at Generic Biologics“–Boston Globe 4/16/07 “Senate HELP Panel to Review Comprehensive FDA Measure“–BioWorld Today 4/16/07 “Eyeing a Lucrative Drug Market“–NJBiz.com 4/16/07 “Biologics Legislation Will…
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Norvasc update: FDA Law Blog reports that the district court has extended FDA’s deadline and that Zydus has filed a new citizen petition. Pharmalot reports on Barr Labs’ efforts to protect its Seasonale oral contraceptive from generic competition. The WSJ Health Blog summarizes today’s front-page WSJ article on Amgen’s recent troubles. The Business Standard and…
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On March 8, the Senate held a hearing on follow-on biologics. Now it’s the House’s turn. Tomorrow morning, the House Oversight Committee, chaired by Rep. Henry A. Waxman (D-CA), will hold a hearing entitled “Safe and Affordable Biotech Drugs–The Need for a Generic Pathway.” Rep. Waxman is the sponsor of the “Access to Life-Saving Medicine…
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The U.S. Senate Committee on Health, Education, Labor, & Pensions held a hearing this morning on follow-on biologics. A complete video recording is available on the hearing web-page. The written testimony of each witness is available on the same page (click on the red icon appearing after each person’s name). In opening remarks, Sen. Kennedy…
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The U.S. Senate Committee on Health, Education, Labor, & Pensions, chaired by Sen. Edward M. Kennedy (D-MA), is planning to hold a full committee hearing on follow-on biologics this Thursday, March 8, at 10 a.m. eastern time. Those expected to testify include Sen. Charles Schumer (D-NY), co-sponsor of the “Access to Life-Saving Medicine Act,” as…
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Most pharmaceuticals made using biotechnology are approved through a Biologic License Application (BLA) rather than a New Drug Application (NDA). The FDA requires essentially the same type of evidence for both biologics and conventional (i.e., small molecule) drugs; namely, results of adequate and well-controlled clinical trials demonstrating safety and effectiveness. However, currently there is no…
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Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application process for biological products. According to the proposed bill, a generic biological product is “comparable,” and therefore approvable in an abbreviated application “if…
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