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Category: Biosimilars
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By Andrew Williams — United States District Judge Seeborg of the Northern District of California denied Amgen's motion for a preliminary injunction today in the Amgen v. Sandoz case, thereby paving the way for the marketing of the first biosimilar in the United States. The Judge also agreed with the interpretation of the Biologics Price…
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By Andrew Williams — As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application — an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic drug product. This is the first such application to be approved using the new biosimilar pathway created by…
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By Kevin E. Noonan — On Friday, the Food and Drug Administration approved a biosimilar version of Amgen's Neupogen® (filgrastim) product for sale in the U.S. This is the first biosimilar to be approved under the provisions of the Biologics Price Competition and Innovation Act (BPCIA), which was part of the healthcare reform package passed…
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By Andrew Williams — Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug. As we previously reported, the Sandoz application is believed to be the first application accepted under the new biosimilar…
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By Donald Zuhn — After reflecting upon the events of the past twelve months, Patent Docs presents its eighth annual list of top patent stories. For 2014, we identified eighteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on patent practitioners and…
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By Kevin E. Noonan — Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation Act, or BPCIA) and how the Act's dispute resolution provisions (also called the "patent dance")…
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By Andrew Williams — Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a receptor fusion protein that binds TNF-α, thereby acting as a decoy receptor molecule. In the Sandoz complaint, it…
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By Kevin E. Noonan — As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab (sold by AbbVie as Humira®). Amgen's press release asserted that the study, aimed at assessing safety and…
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By Anthony Sabatelli* — Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple.1 For those of you not yet familiar with this latest trend, allow me to explain. Most drug products are small, synthetically produced substances. The common pain reliever ibuprofen,…
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By Paul Tully — The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved biosimilar alternatives to the biologic drugs, termed the "List of Licensed Biological Products with Reference…
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