Biosimilars & Generics

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.

Inflation accounted for a larger portion of user fee revenue target increases for fiscal year 2025, compared to previous years, according to a Pink Sheet analysis.

The US PTO faces criticism after withdrawing a proposed rule intended to address double-patenting by changing terminal disclaimers.

An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

Two more generics manufacturers have settled claims with 50 US attorneys general that they artificially inflated and manipulated the prices of generic drugs for nearly a decade.