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SCD accelerates EU approval of Eylea biosimilar

By Nho, Byung Chul | translator Kim, Jung-Ju

23.10.04 09:02:53

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Expect to receive the final report in October, entering the final negotiation stage



SCD announced on the 4th that it had decided to proceed with final negotiations after receiving confirmation of the details of the due diligence conducted for three days from September 6th to 8th by the Eylea biosimilar European partner company.

Inspectors designated by the European partner company visited the SCD Eylea biosimilar CMO production site and inspected production facilities and GMP regulations for three days. As a result, it was concluded that there were no problems with the application for European EMA approval, and it was reported that the first result was confirmed on September 26th. An SCD official said, ¡°This extension of the Binding Term Sheet deadline is not because there was a prob

Nho, Byung Chul(sasiman@dailypharm.com)
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