Biosimilars & Generics
Biosimilars
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.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
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.
Generics
Sandoz announced a $275m settlement to resolve class action antitrust litigation over price-fixing allegations and disclosed that the company made a further provision of $265m linked to the case.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
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.