Patent Law Weblog
Category: Food and Drug Administration
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By Kevin E. Noonan – Today, the Supreme Court again disregarded the views of the Federal government regarding whether to grant certiorari, here in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, and in some ways the only positive outcome is that the Court has shown it is willing to refuse to take action is cases other than…
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By Kevin E. Noonan – On November 18th, the U.S. Food and Drug Administration (FDA) announced its approval of Eli Lilly's Rezvoglar (insulin glargine-aglr) product as an interchangeable biosimilar to Sanofi's Lantus (insulin glargine). Both the reference product and the interchangeable biosimilar are "long-acting human insulin analog[s] indicated to improve glycemic control in adults and pediatric patients…
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By Kevin E. Noonan — On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between different versions of small molecule drugs. The definition of "therapeutic equivalence" in the Guidance is: [A]pproved drug products that FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can…
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By Kevin E. Noonan — On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. RESTASIS® is "a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to…
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By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and…
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By Kevin E. Noonan — The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). This brings to 33 the total number of…
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By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)." The Final Guidance provides its Answers in…
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By Kevin E. Noonan — On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August 25, 2017. In this recent approval, the FDA determined that Cyltezo is interchangeable with AbbVie's Humira (adalimumab), its reference product. Cyltezo…
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By Kevin E. Noonan — The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). The drug is Byooviz…
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By Kevin E. Noonan — Last week the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it is the first approved interchangeable biosimilar product. The product is Semglee (insulin glargine-yfgn), produced by Mylan Pharmaceuticals, Inc., and under this approval, it is interchangeable with Lantus (insulin glargine) made…
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