1. Pink Sheet

For US Trastuzumab Biosimilars, Development Time Did Not Predict Speed To Market

 
• By Sue Sutter

Amgen/Allergan's Kanjinti had second longest development time among five licensed biosimilars to Genentech's Herceptin but was the first to reach market, according to a Pink Sheet timeline of development and regulatory milestones for the follow-on products.

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Speed to approval does not always equate to speed to market. • Source: Shutterstock

In a US biosimilars market complicated by patent disputes and legal settlements, development and regulatory review speed do not necessarily correlate with time to market entry.

Case in point: Amgen Inc. and Allergan PLC’s Kanjinti (trastuzumab-anns), the most recent of five biosimilars to Genentech Inc.’s Herceptin approved by the Food and Drug Administration...

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