Carol Lynch: Instilling Confidence in Biosimilars

Transcript:

What kind of responsibility does the FDA have to assure providers and patients that biosimilars are safe and effective products?

So obviously, FDA play a clear role in educating all stakeholders around the misinformation [about biosimilars], but they also have an important role in terms of the confidence that they can instill in physicians and patients around biosimilars. These products undergo a rigorous review by FDA and patients and healthcare providers alike should be confident in their efficacy and the safety and the quality of the products. FDA could help us with that by reinforcing that confidence when new approvals are announced, for example.