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The European Commission has notified the Israeli pharmaceutical company that its initial findings were that Teva violated EU antitrust laws over practices delaying competition for Copaxone.

In December 2020, the U.S. District Court for the District of Columbia issued a Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone ®, a medication for treating multiple sclerosis, is a “drug” rather than a “biological product.” Biologic products are regulated under the Biologics Price Competition and Innovation Act ( BPCIA), which has more arduous requirements for approval of follow-on biosimilar or interchangeable products than those for generic drugs. Following several failed efforts to have FDA reclass...

Share this article Share this article EXTON, Pa., Feb. 11, 2021 /PRNewswire/ -- With the recent additions of Novartis' Mayzent, Bristol Myers Squibb's Zeposia, and Biogen's Vumerity to the multiple sclerosis (MS) market in the United States, neurologists increasingly choose to initiate treatment by prescribing an oral disease-modifying therapy (DMT). Data from 1,018 charts of MS patients initiated on their first DMT within the prior three months, provided by 205 neurologists as part of Spherix's RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) service, indicate that the oral D...