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Mylan NV

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Latest From Mylan NV

FDA Approves Amgen And Allergan’s Kanjinti Trastuzumab Biosimilar

Amgen and Allergan’s biosimilar version of Herceptin has been approved by the US Food and Drug Administration.

Biosimilars United States

FDA Is Urged To Make All Biosimilar Insulins Interchangeable

As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.

Regulation Biosimilars

Australia Aims To Drive Etanercept Uptake By Broadening Brenzys Listing

Australian authorities are looking to drive uptake of biosimilar etanercept by broadening a reimbursement listing for MSD’s Brenzys, while an advisory committee continues to ponder listings for trastuzumab biosimilars.

Regulation Biosimilars

US FDA Makes Flexibility Look Routine In TB Drug Review, But Not Everyone Is Pleased

The most remarkable aspect of the positive advisory committee for pretomanid is how routine FDA’s flexibility in the face of unmet need is starting to feel – but there are some dissenting voices that merit attention. 
Advisory Committees Drug Approval Standards
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