Plant issues plague Celltrion and Teva as FDA issues two biosimilars CRLs

By Dan Stanton

- Last updated on GMT

The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrion’s facility received a warning in Janaury.

In 2016​, Israeli drugmaker Teva Pharmaceutical Industries entered into a $160m (€130m) biosimilar pact for the potential commercialisation of two biosimilars with South Korean manufacturer Celltrion.

The biosimilars – versions of Roche’s Rituxan (rituximab) and Herceptin (trastuzumab) – were submitted for regulatory review last year​, but the US Food and Drug Administration (FDA) has not approved either, Celltrion told this publication.

Celltrion received complete response letters (CRLs) from the US Food and Drug Administration regarding the Biologics License Application (BLA) for its Rituxan and Herceptin biosimilar respectively,”​ spokesperson HeeWon Park said.

The news comes weeks after Celltrion was hit by a warning letter​ at the site, highlighting “multiple poor aseptic practices” ​observed during an inspection in May and June last year, and which according to Park was directly related to the rejection.

The FDA Warning Letter issued to Celltrion on January 26, 2018 contributed in part to the receipt of the CRL. 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 added ​the resubmission will be in-place relatively soon. "Then, we are expecting approvals in 6 months after resubmission according to regulatory timeline."


A spokesperson from Teva told us the firm will "continue to work closely with Celltrion with the goal of bringing the proposed trastuzumab and rituximab biosimilars to market in the US. Teva remains committed to gaining FDA approval and to bringing these products to market."

The CRL is not a good sign for Teva’s anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody, fremanezumab, the active pharmaceutical ingredient (API) for which is made at the same site.

The candidate was submitted for regulatory approval last year, and the FDA has set a date of mid-June for its decision.

Fremanezumab – formerly known as LBR-101 – was added to Teva’s pipeline through the acquisition of Labrys Biologics in 2014​​ in a deal worth up to $825m.

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