Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Biosimilars
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It's been two years since Congress passed the Biologics Price Competition and Innovation Act, and FDA is still waiting to receive the first biosimilar application. But that doesn't mean progress hasn't been made. FDA issued three draft guidance documents in February, and various companies and industry groups have submitted comments on the guidance (see this…
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In a press release today, the FDA announced the publication of three draft guidance documents on biosimilar product development "to assist industry in developing such products in the United States." FDA is seeking public comment on the draft guidance documents. The three guidance documents are: Scientific Considerations in Demonstrating Biosimilarity to a Referenced Product–intended to…
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The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington. Speakers include industry leaders, government officials, outside counsel and others. The agenda includes the following presentations: Welcoming remarks, FTC Commissioner Pamela Jones Harbour Opening remarks, Rachel Behrman, FDA: "How Do Biologic Drugs Differ…
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Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt. For more: AP; Reuters; WSJ. Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis. Sanofi already owns 25% of the company. Meanwhile, the WSJ Health Blog recently reported that the CEOs…
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Biopharmaceuticals, such as Epogen® (epoetin) and Erbitux® (cetuximab), are becoming increasingly important for the treatment of disease. U.S. sales of such drugs were about $40 billion in 2006 and are expected to rise to over $90 billion in 2009. Accordingly, political pressure is building to allow the sale of “biosimilar” drugs. Inspired by the…
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Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), spent some quality time this afternoon answering questions from bloggers about follow-on biologics, patent reform, and FDARA/PDUFA legislation. Mr. Greenwood said that follow-on biologics are a "critical, critical issue" for BIO. From BIO's perspective, the ideal bill would reflect and parallel the Hatch-Waxman Act. It would…
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MarketWatch.com is reporting this afternoon that the Senate Committee on Health, Education, Labor and Pensions has voted in favor of the Biologics Price Competition and Innovation Act of 2007. It is unclear whether the Committee amended the bill before voting on it. The bill will now move to the Senate floor. RELATED READING: Bloomberg Pharmalot
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After several previous bills went nowhere, lawmakers may have finally reached a viable compromise on follow-on biologics legislation. Last Friday, a bipartisan group of Senators led by Ted Kennedy (D-MA) and Orrin Hatch (R-UT) announced an agreement on a new bill that would establish an abbreviated pathway for FDA approval of biologic drugs. The Senate…
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Pharmalot had this post Friday about a new bipartisan follow-on biologics bill in the Senate. MarketWatch reported Friday that European regulators have moved a step closer to approving Sandoz’s follow-on version of J&J’s blockbuster Eprex, sold in the U.S. as Procrit. On Thursday, a House committee marked up the PDUFA reauthorization legislation (Pharmalot). PhRMA reacted…
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