HomeNewsfremanezumab, migraine, migraine prevention, preventive migraine, prophylactic migraine, tevaCRLs, leading to fremanezumab launch delay in Migraine, acknowledged by Celltrion

CRLs, leading to fremanezumab launch delay in Migraine, acknowledged by Celltrion

  • April 10, 2018
  • Posted by: PharmaScroll
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Celltrion in a statement issued, on April 6th 2018, acknowledged receiving the Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for CT-P10 (rituximab), a proposed biosimilar to Rituxan® and CT-P6 (trastuzumab), a proposed biosimilar to Herceptin®.

Celltrion in its statement highlighted that The FDA Warning Letter issued to Celltrion in January 2018 was directly related to the receipt of the CRL.

The company further stated that, “Celltrion is making progress addressing the concerns raised by the FDA in a Warning Letter issued in January and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency. Celltrion is confident that the issues raised by the FDA will be resolved in a timely manner. We can confirm that the resubmission will be in-place relatively soon. Then, we are expecting approvals in 6 months after resubmission according to regulatory timeline.”

It may be noted that the issue of CRLs to Celltrion had potentially delayed the launch of Teva’s Migraine drug fremanezumab by 6 months. Teva CEO Kåre Schultz had highlighted in the fourth-quarter earnings call that, “We are in active dialogue with FDA in order to ensure that this warning letter would not affect the supplies of API from Celltrion to our fremanezumab program. We are optimistic that we would be able to prove that the API manufacturing is in good shape, but it, of course, remains to be settled in a discussion with FDA.”

In Pharmascroll’s view, the clearance of FDA reservations regarding Celltrion facility might take some more time and Teva might experience some delay in the launch of fremanezumab. The delay in the launch of Teva’s Migraine drug would be the gain for other companies including Amgen/Novartis and Eli Lilly who would be fighting hard to take majority share of the non differentiated anti-CGRP space in Migraine preventive treatments.

 

About Pharmascroll:

Pharmascroll is a diligent business consulting and market research firm focused solely towards pharmaceutical markets. The company consults and researches in majorly chronic disease indications prevalent across the globe. The research conducted by Pharmascroll analysts is targeted to provide analytical and logical answers to the key business questions of the pharmaceutical and medical insights teams and to make better informed business decisions with the detailed relevant information available.

To read more news about Migraine, visit https://pharmascroll.com/news-category/migraine/

 

News Source: https://www.celltrion.com/en/pr/newsDetail.do?seq=482

Image Source: https://www.bakeawards.co.ke/2016/03/02/kenyan-blog-awards-delay-in-voting-phase-launch/