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- Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits
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Category: Biosimilars
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By Donald Zuhn — The Senate patent reform bill may or may not be dead (see "Bush Administration Continues Attempt to Destroy U.S. Patent System"). However, if the bill’s time has indeed come and gone (at least as far as the 110th Congress is concerned), its passing will be due in no small…
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By Kevin E. Noonan — Biologic drugs, the pharmaceutical embodiments of biotechnology, are an important part of the current pharmaceutical armamentarium, and this is only expected to increase. There are 150 approved biologic drugs in the U.S., contributing $40 billion to U.S. drug costs in 2005; these costs are expected to increase to…
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By Donald Zuhn — Last week, we reported on a campaign being initiated by Insmed Inc. to raise public awareness regarding the importance of establishing a regulatory pathway in the U.S. for follow-on biologics. As part of the campaign, Insmed commissioned a study by economist Dr. Robert J. Shapiro (at right) to determine…
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By Donald Zuhn — Earlier today, Patent Docs participated in a conference call with Jim Greenwood, the President and CEO of the Biotechnology Industry Organization (BIO). Mr. Greenwood, who represented Pennsylvania’s Eighth District in the U.S. House of Representatives from January 1993 through January 2005 prior to his BIO appointment, had invited a…
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By Donald Zuhn — Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) approved three new follow-on biologic drugs: Binocrit (Sandoz GmbH), Epoetin alfa Hexal (Hexal Biotech Forschungs GmbH), and Abseamed (Medice Arzneimittel Pütter GMBH & Co.). The approved biosimilars are generic versions of Johnson…
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By Donald Zuhn — Last month, the European Medicines Agency (EMEA) released a paper entitled "Questions and Answers on biosimilar medicines (similar biological medicinal products)," in which the EMEA provided answers to a number of questions concerning the authorization of biosimilars. The European biosimilar regulatory pathway was established in 2004. In view of…
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By Donald Zuhn — Last week, the U.S. Senate Committee on Health, Education, Labor & Pensions announced that it had passed the Biologics Price Competition and Innovation Act. According to a Committee press release, the bill (S. 1695) "includes standards for the FDA to approve follow-on biologics, a procedure designed to help resolve…
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