Amgen Eyeing ‘Sustainable Opportunities’ In Non-US Biosimilars Markets
As it begins reporting biosimilars sales after embarking on the journey a decade ago, Amgen says it will target sizeable European countries possessing more “balanced dynamics,” such as France and Germany, for its biosimilar franchise. The California-based biotech also remains upbeat about the potential to make serious inroads in the US biosimilars market.
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Biocon rang in a strong Q3, buoyed by the momentum in its biologics business. The firm appears undeterred by suggestions that the US biosimilars market may be less attractive than initially anticipated.
Products Roundup - 19 December 2018: European Commission Approves Mylan/Biocon’s Ogivri Biosimilar, Amgen Files Infliximab With The FDA And Hikma Debuts Dalfampridine
The latest generic, biosimilar and value-added drug development news and highlights from across the globe.
Amgen received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its Kanjinti (trastuzumab) biosimilar following a recent target action date, the company has disclosed to Generics bulletin. Responding to enquiries, an Amgen spokesperson said the response letter – informing the firm that its biologics license application (BLA) is not yet ready for approval – was not expected to “impact our US launch plan”. The US-based firm, however, did not expand on its launch strategy.