Teva faces delay in biosimilars launch

Kare Schultz Photo: PR

Teva is meant to commercialize generic versions of oncology drugs Herceptin and Rituxan produced by Korean company Celltrion.

While Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA; TASE: TEVA) competitors have in recent years forged ahead in the biosimilars market - development generic versions of biological drugs - Teva has lagged behind.

In 2009, Teva did sign a collaboration agreement in this area, but the agreement was canceled a few years later. In order not to miss this large market completely, in 2016 Teva signed a licensing agreement costing $160 million with Korean company Celltrion Healthcare, which develops biosimilar drugs.

Teva is supposed to commercialize the generic versions of best-selling oncological drugs Herceptin and Rituxan, which have annual sales in the US of $6.5 billion. Last week, however, there was a delay, when the US Food and Drug Administration (FDA) wrote to Celltrion with additional requirements before marketing approval can be given. This follows a recent warning letter from the FDA to Celltrion. The launch of the drugs from which Teva was meant to benefit has thus been postponed.

An additional potential delay for Teva arising from its relationship with Celltrion relates to its original migraine treatment fremanezumab. Celltrion produces the active ingredient in the drug for Teva, and the warning letter to Celltrion from the FDA is expected to delay marketing approval for the drug, which was due to have been obtained this June. This is despite the fact that the warning letter is not directly connected to the part of the plant that produces active pharmaceutical ingredients. Teva is in discussions with the FDA on the matter, but the assessment is that the drug will be launched late.

Credit Suisse analysts write that Teva does not know at this stage when the biosimilar drugs will be launched, but that the company still believes that there will be no delay in the launch of the migraine treatment.

Published by Globes [online], Israel business news - www.globes-online.com - on April 8, 2018

© Copyright of Globes Publisher Itonut (1983) Ltd. 2018

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Kare Schultz Photo: PR
Kare Schultz Photo: PR
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