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Sandoz Inc.

Division of Novartis AG
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Latest From Sandoz Inc.

Teva Sues FDA For Excluding Copaxone From BLA Transition

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Legal Issues Biosimilars

Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process

Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.

Biosimilars Legal Issues

FDA And FTC Offer Advice On Biosimilar Barriers

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

Biosimilars FDA

FDA/FTC's Hot Ticket: Biosimilar Workshop On How To Boost Market, From Education To Lawsuits

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

Biosimilars FDA
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