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Mylan NV

www.mylan.com

Latest From Mylan NV

Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

BioPharmaceutical Regulation

Enthusiasm For US Biosimilars Wanes For Some, But Not Others

Three years after the first biosimilar launched in the US, the market has failed to deliver notable return on investments. Some players like Mylan are going public with frustrations over market barriers, while others, like Amgen, say they are encouraged by steady progress. Teva, however, is limiting its investment in biosimilars.

Biosimilars Commercial

Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention

Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.

Biosimilars Intellectual Property

Legality Of J&J's Remicade Contracting Depends On Share Of Biosimilar Market Foreclosed, Court Rules

Court denies J&J's motion to dismiss Pfizer's antitrust suit, saying discovery will reveal whether Pfizer has offered more competitive pricing for its Inflectra biosimilar and if there are alternative causes for Pfizer's inability to gain market share.

BioPharmaceutical Policy
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