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PITTSBURGH and BENGALURU, India, July 28, 2021 /PRNewswire/ Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee
® (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
Biocon Biologics
Viatris CEO Michael Goettler commented: We are extremely proud to achieve the industry s first approval of an interchangeable biosimilar product in the U.S., which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers. This is yet another important milestone for our company that not only continues to underscore the strength of our internal scientific capabilities, but also supports our belief in the promising future of our company as we continue to work to identify innovative ways to increase access to complex treatments f
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Mylan Wins Significant Summary Judgment Rulings in Kansas EpiPen® Class Action
Company Confident Evidence Regarding Only Remaining Claim Will Show Mylan s Actions Were Lawful and Pro-competitive
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PITTSBURGH, June 23, 2021 /PRNewswire/ Viatris (NASDAQ: VTRS) today announced that the U.S. District Court for the District of Kansas ruled, in substantial part, in Mylan s favor on the company s summary judgment motion in the class action related to EpiPen® Auto-Injector.
The company is pleased with the court s decision to dismiss all of the plaintiffs claims under the federal RICO statute, which include claims asserted against Mylan s former CEO Heather Bresch. The court also dismissed claims alleging that Mylan foreclosed branded competition through rebate arrangements with pharmacy benefit managers.