• 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

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted for approximately half of U.S. healthcare medicine spending in the past few years. While biosimilars have offered

Introduction

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products.  The draft guidance – the first of its kind from the agency – aims to enhance the efficacy and accuracy of the drug approval process, ensuring that applications incorporating AI meet rigorous

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with Regeneron Pharmaceuticals, Inc. (“Regeneron”).[1] The Federal Circuit affirmed the district court’s exercise of personal jurisdiction over both defendants as well as the entries of preliminary

The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a combination drug used to treat heart failure.

Following a three-day bench trial, Judge Andrews found the ’659 patent not invalid for obviousness, lack

  • 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

Artificial Intelligence (AI) has long been associated with science fiction movies about dystopian futures, leading to fear among the general public about its potential impact. This is especially the case today for those in academia who have graded countless papers written by ChatGPT. However, the truth is far from what we see in the movies.

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers.  These biologic medicines, which are highly similar to existing biological products and are designed to be as effective and safe as the brand name drugs, offer the potential to provide