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  • Many Prolia®/Xgeva® (denosumab) biosimilars approved in 2025 by FDA and EMA.
  • FDA grants first interchangeable status for rapid acting insulin aspart, KristyTM.
  • EMA sets record with 44 biosimilar authorizations in 2025.

Biosimilars continue to make a significant impact on global healthcare.  These products are highly similar to an already-approved reference product, offering a…

The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication. The decision, issued on July 11, 2025, potentially clears the path for generic entry before expiration of U.S. Patent No. 11,096,918 (“the ’918 patent”) on November…

  • FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
  • After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more…

  • FDA and EMA both approve biosimilar versions of Stelara® (ustekinumab), Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab).
  • FDA approves 19 biosimilars in 2024.

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare.  These products are highly similar to an already-approved reference product, offering a more affordable…