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Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals

Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…

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Biosimilar and Biologic Updates in China: Bevacizumab, Etanercept, Tislezumab, Infliximab, Eculizumab, Adalimumab

The past few weeks have seen the following biosimilar developments in China: On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. On December 30, 2019,…

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Federal Circuit Affirms Biosimilar-Related IPR Appeals; Bevacizumab Injunction Appeal Progresses

Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein purification method IPR appeal Today, the Federal Circuit issued a 2-1 opinion affirming a 2018…

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Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation (UPDATED)

This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed…

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DEAL WATCH: End-of-Year Biosimilar Agreements

Following the string of biosimilar agreements announced in early November, a number of additional transactions were announced in early December, bringing 2019 to a roaring close with global biosimilars deals. On December 1, 2019, Luye Pharma Group announced that it acquired Shandong Boan Biological Technology Co. Ltd. (Boan), strengthening its…

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Another Biosimilar Litigation Settlement: Amgen v. Tanvex (Filgrastim)

Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “to the dismissal, without prejudice, of all remaining claims and counterclaims in…

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