<span id="midArticle_start"/><span id="midArticle_0"/> Novartis AG unitSandoz asked a U.S. appeals court on Wednesday to lift apreliminary injunction barring it from selling its biosimilarZarxio, a cheaper version of a drug that fends off infections incancer patients.
<span id="midArticle_1"/>In October, Amgen Inc, maker of the $1.2billion-a-year drug Neupogen, sued Sandoz in district court inSan Francisco, saying Zarxio infringed the patent on Amgen'sdrug. The court refused to grant a preliminary injunctionbarring the sale of Zarxio while the lawsuit continued, but inMay the injunction was granted by the U.S. Court of Appeals forthe Federal Circuit.
<span id="midArticle_2"/>The hearing on Wednesday was to discuss if the FederalCircuit's order would remain.
<span id="midArticle_3"/>Zarxio is a biosimilar, which is essentially a close copy ofa brand name biologic medicine. Since biosimilars are copies ofbiologic products, which are made of living cells, they are notconsidered exact duplicates. Insurers hope they will cost thepublic 40 percent to 50 percent less than the original brands.
<span id="midArticle_4"/> <span class="first-article-divide"/>Zarxio would become the first biosimilar sold in the UnitedStates.
<span id="midArticle_5"/>Much of the discussion on Wednesday focused on whetherSandoz had made appropriate disclosures to Amgen that it plannedto bring out a copy of Neupogen, as the law requires.
<span id="midArticle_6"/> <span class="second-article-divide"/>Sandoz lawyer Deanne Maynard of Morrison Foerster said thecompany had done so twice, once when it applied for approval forZarxio from the Food and Drug Administration and again when itreceived that approval.
<span id="midArticle_7"/>Judge Raymond Chen, sitting on a panel of three, appeared todiscount the notice given at the time of the application.
<span id="midArticle_8"/> <span class="third-article-divide"/>"You don't have any clue as to whether your application willbe approved," he said.
<span id="midArticle_9"/>Arguing for Amgen, Nicholas Groombridge of Paul, Weiss,Rifkind, Wharton & Garrison said Sandoz had failed to followregulations about how notice is to be given on the launch of abiosimilar.
<span id="midArticle_10"/>"Sandoz didn't follow the rules," he said.
<span id="midArticle_11"/>The case is Amgen Inc v Sandoz, U.S. Court of Appeals forthe Federal Circuit, No. 2015-1499. (Editing by Ted Botha and Marguerita Choy)
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<span id="midArticle_1"/>In October, Amgen Inc, maker of the $1.2billion-a-year drug Neupogen, sued Sandoz in district court inSan Francisco, saying Zarxio infringed the patent on Amgen'sdrug. The court refused to grant a preliminary injunctionbarring the sale of Zarxio while the lawsuit continued, but inMay the injunction was granted by the U.S. Court of Appeals forthe Federal Circuit.
<span id="midArticle_2"/>The hearing on Wednesday was to discuss if the FederalCircuit's order would remain.
<span id="midArticle_3"/>Zarxio is a biosimilar, which is essentially a close copy ofa brand name biologic medicine. Since biosimilars are copies ofbiologic products, which are made of living cells, they are notconsidered exact duplicates. Insurers hope they will cost thepublic 40 percent to 50 percent less than the original brands.
<span id="midArticle_4"/> <span class="first-article-divide"/>Zarxio would become the first biosimilar sold in the UnitedStates.
<span id="midArticle_5"/>Much of the discussion on Wednesday focused on whetherSandoz had made appropriate disclosures to Amgen that it plannedto bring out a copy of Neupogen, as the law requires.
<span id="midArticle_6"/> <span class="second-article-divide"/>Sandoz lawyer Deanne Maynard of Morrison Foerster said thecompany had done so twice, once when it applied for approval forZarxio from the Food and Drug Administration and again when itreceived that approval.
<span id="midArticle_7"/>Judge Raymond Chen, sitting on a panel of three, appeared todiscount the notice given at the time of the application.
<span id="midArticle_8"/> <span class="third-article-divide"/>"You don't have any clue as to whether your application willbe approved," he said.
<span id="midArticle_9"/>Arguing for Amgen, Nicholas Groombridge of Paul, Weiss,Rifkind, Wharton & Garrison said Sandoz had failed to followregulations about how notice is to be given on the launch of abiosimilar.
<span id="midArticle_10"/>"Sandoz didn't follow the rules," he said.
<span id="midArticle_11"/>The case is Amgen Inc v Sandoz, U.S. Court of Appeals forthe Federal Circuit, No. 2015-1499. (Editing by Ted Botha and Marguerita Choy)
<span id="midArticle_12"/>
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