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Basaglar (Insulin Glargine Injection) Launches in US

Eli Lilly and Boehringer Ingelheim announced today that their insulin glargine injection product, Basaglar® (a follow-on biologic for Sanofi’s Lantus®), is now available by prescription in the U.S. Although Basaglar is approved as a biosimilar for Lantus in Europe, in the U.S., Basaglar is not technically considered a biosimilar.  In the U.S.,…

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European Crohn's and Colitis Organisation Supports Switch to Biosimilars

The European Crohn’s and Colitis Organisation (“ECCO”) released a statement last week supporting the switch from the reference infliximab to biosimilar infliximab in patients with inflammatory bowel disease (“IBD”).  ECCO’s new position is particularly significant, given its earlier position taking a cautious approach to biosimilars and suggesting that “rigorous testing [of biosimilars]…

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Breaking News: Supreme Court Denies Cert. in Apotex v. Amgen

Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA.  Our most recent blog coverage can be found here. Even though the Court has declined to hear Apotex v. Amgen, the Supreme Court has before it another vehicle for addressing the hotly-contested…

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Analysis of Solicitor General's Brief in Sandoz v. Amgen

As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th,  filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret important provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and…

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Celltrion and Hospira Have Launched Inflectra® in U.S.

This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®.  According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively, “Celltrion”) have now launched Inflectra® in the United States.  On December 6, Celltrion stated that it “recently launched in the United…

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Updates on Rituximab Proposed Biosimilars

The past few days have seen a lot of activity on the rituximab biosimilar front. According to a joint press release, Sanofi and JHL Biotech, a biopharmaceutical company based in China, formed an alliance to collaborate on the development and commercialization of a rituximab biosimilar and various pharmaceutical products in China….

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Mylan-Biocon Publish Positive Results for Proposed Trastuzumab Biosimilar

Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab).  Earlier this week, an article published in the Journal of the American Medical Association (JAMA), titled Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2…

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