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Latest From Legal Issues

Biosimilar Litigation: Janssen Vs. Samsung Anticipates Supreme Court Decision

Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.

Biosimilars Legal Issues

Off-Label Discussion, But No Additions, For House User Fee Bill

Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.

United States Advertising, Marketing & Sales

‘Excessive Pricing’ Inquiry Widens As EC’s First Antitrust Price Probe Targets Aspen Pharma

The litany of complaints against pharmaceutical companies for imposing “excessive” prices on generic drugs is growing after the European Commission decided to pursue Aspen Pharma over price rises imposed on a range of anticancer products it acquired from GSK.

Pricing Strategies Europe

Biosimilar Tentative Approvals Could Flow From US Supreme Court Case

If high court decides that biosimilar sponsors must wait until licensure before providing 180-day notice of commercial launch, FDA may face pressure to start granting tentative licenses for 351(k) applications, industry lawyer says.

Biosimilars Legal Issues

Price-Fixing: Steakhouse Dinner, Emails Do Not Show Conspiracy, Generic Firms Contend

Companies argue why 40 US attorneys general have no antitrust case against them in joint and individual motions to dismiss complaint.

Legal Issues Pricing Debate

ANDA Case Filings Drop 32%, But Still High Compared To Last Decade

Lex Machina reports that 316 ANDA cases were filed in 2016 compared to 468 in 2015; number of inter partes review petitions filed on Orange Book patents has declined since 2015.

BioPharmaceutical Policy
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