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Set Alert for Regulation

Belgium Unveils Incentives For Biosimilar Adalimumab And Etanercept

Belgium has introduced financial incentives to encourage doctors to prescribe anti-TNF biosimilars adalimumab and etanercept outside of hospitals.

Belgium Biosimilars

Wockhardt Wins Review Of Ban On Indian Combination

Evidence put forward by manufacturers to support fixed-dose combinations must be considered by an advisory committee to India’s government, the Delhi High Court has ordered in a verdict favouring Wockhardt.
India Regulation

Remodulin And Revlimid Rivals Join France’s Répertoire

Almost 20 new generic groups – including rivals to Flecaine, Inegy, Remodulin and Revlimid – have been added to France’s répertoire of generic equivalents following the latest update by local medicines agency ANSM.

France Generic Drugs

FTC Grants Teva's Request To Reopen Watson-Actavis Merger

The FTC will allow Teva to continue to supply the Embeda brand to Pfizer in 2019, despite Teva having taken several years to bring its in-development generic version to market.

United States Regulation

Belgian Body Bolsters Awareness Of Biosimilars

Belgian medicines agency AFMPS has launched a public information campaign to educate patients on biologics and to encourage the uptake of biosimilars.

Belgium Regulation

FDA’s Gottlieb Rolls Out A Raft Of Biosimilar Reforms

As the FDA publishes several key guidance documents on biosimilars and biologics, Commissioner Scott Gottlieb has outlined the latest steps in the agency’s ongoing efforts to support the market. These include measures to address the abuse of REMS, as well as transitioning products such as insulin and human growth hormone into the biologics framework.

United States Biosimilars
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