JD Supra

FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy

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 ...
Monthly Prescribing Reference

Biosimilars in Oncology: Barriers to Wider Use

Source: Getty Images Factors preventing use of biosimilars in oncology include the cost and complexity of development, oncologists’ lack of knowledge, and interactions between payers and pharmacy ...
STAT

The biosimilar market looks unsustainable right now, and that’s a problem

Within ten years, a patient may find that even a decades-old biologic treatment option they need has no other lower-cost alternative — and the one that’s available is prohibitively expensive and not ...
JD Supra

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

Biological products, or biologics, are large, complex molecules produced in living systems such as therapeutic proteins, antibodies, and gene- or cell-based therapies. Under the Public Health Service ...