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Sun Adds To Criticism Over Medicare 505(b)(2) Policy

Sun And Taro Say Proposal Would Likely Stifle Competition And Raise Costs

Executive Summary

Sun Pharma and its US Taro subsidiary have added to criticism over a recent CMS policy proposal that would see Medicare Part B drugs approved under the US hybrid 505(b)(2) pathway reimbursed at a lower rate applicable to multiple source products.

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Industry Urges Medicare Rethink On 505(b)(2) Policy

Teva, Sun and the AAM are among those urging the CMS to rescind its proposal to reimburse Part B drugs approved under section 505(b)(2) as multiple source products. The proposal would target one relatively small but growing part of Medicare Rx spending and reflects CMS’ ongoing concern with fast rising costs in the program.

Bio-Thera Ventures Outside China With European Bevacizumab Filing

China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.

EU Pharma Strategy Will Remove Barriers And Bolster Competition

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

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