韩国celltrion被发warning letter延迟其合作方Teva上市延迟

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韩国celltrion被发warning letter后很可能延迟其合作方Teva上市延迟
虽然celltrion是在制剂方面被警告，但是由于涉及到数据完整性的问题，其也很可能影响到在该地址上和Teva合作的原料药生产，从而可能将产品的上市时间推迟至2019年

Celltrion's manufacturing headache likely to delay Teva migraine drug until 2019: analysts

由 Joseph Keenan

FiercePharma: Pharma / 2018-03-16 11:14

Teva officials said last month that their migraine drug fremanezumab, a linchpin of their growth plans, might not be delayed by "limited" problems at the Celltrion plant where its active ingredient would be made. But experts say those problems probably aren't as limited as Teva might have hoped.

After reviewing FDA warnings issued to Celltrion, a drug manufacturing specialist told Leerink that the agency cited issues that likely extend beyond the plant's fill/finish operations, the firm said in an investor note. The Celltrion facility would be Teva's main API supplier for fremanezumab.

“The specialist believes that while the inspection that resulted in the Form 483 and Warning Letter was done only at the fill/finish part of the facility, many of the observations cited, particularly around data integrity, could be present at the API manufacturing part of the facility as well,” the Leerink analysts said.

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And that means Teva's likely to face a delay in rolling out fremanezumab until mid-2019, the analysts wrote.

“The specialist believes that as long as Teva continues to source fremanezumab's API from the Celltrion facility with an outstanding Warning Letter, it is very unlikely the FDA will approve the product,” the note stated.

Although Teva has said it plans to source the API from another manufacturer, Leerink's analysts contended that switching API suppliers isn’t “a near-term option” and that the only successful path to gaining FDA approval for fremanezumab “is the resolution” of the issues at the Celltrion facility.

In announcing the potential delay in February, Teva CEO K

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TEVA也不怎么样