Biosimilars are near-identical versions of biologic cancer drugs, available at lower costs. Germany saves hundreds of millions annually from just one biosimilar drug. Patient mistrust and policy ...
The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...
Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...
The U.S. Food and Drug Administration (FDA)’s March 2026 update to its biosimilar Q&A guidance arrives at a critical inflection point for the biopharmaceutical sector, as the industry faces a looming ...
In 2024, the use of generic and biosimilar medicines saved $467 billion for the United States health-care system and the patients who use it, according to a recent report by the Association for ...
The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...
The Association for Accessible Medicines and the Biosimilars Council have released the 2025 U.S. Generic & Biosimilar Medicines Savings Report. AAM’s annual savings report highlights that generic and ...
Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars is a biologic medication that is highly similar to an ...
Biosimilars are gaining traction as competitors aim to capture market share from branded biologics such as Humira and Neulasta. Humira now faces competition from seven biosimilars, while Neulasta has ...
While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the ...
Without policy intervention to address average sales price-based challenges to biosimilar market sustainability, there is a threat of biosimilar exits from the market and fewer new biosimilars being ...
Fact: branded biologic drugs are consistently among the most expensive in our healthcare system. 1 Compounding this, chronic conditions – often treated with biologics – are becoming increasingly ...
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