Features

26 June 2012

Biosimilar Medicinal Products: Innovation in Regulatory Review and Approval

By Kathryn Wekselman, PhD, RN

The approval and regulation of biosimilar medicinal products (biosimilars) are areas of notable regulatory innovation right now and for the foreseeable future. This article reviews the state of biosimilar approval and regulation, with an emphasis on how innovation in regulatory practices, and related innovation in science and drug development, is affecting the process of bringing biosimilars to market. [Read More...]

---

3 April 2012

US Biosimilar Guidelines: Summary and Insights

By Kamali Chance, MPH, PhD, RAC

In March 2010, section 351(a) of the Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products that were found to be highly similar to US Food and Drug Administration (FDA) licensed biologics. This article explores recent FDA guidance pertaining to biosimilar products. [Read More...]

---

5 March 2012

Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

By HA Dowlat and Karl-Ludwig Rost

This article presents a European perspective of biosimilar development with a focus on PK/PD, which helps provide context to an interpretation of the three new draft guidances from the US Food and Drug Administration (FDA) published in February 2012. [Read More...]

---