ViewPoints: Celltrion looks to curb fears that biosimilar Rituxan programme has been delayed

Just days after Celltrion CEO Seo Jeong-jin announced plans to sell his controlling stake in the South Korean biotechnology company (see ViewPoints: Celltrion confident of EU approval for biosimilar Remicade by mid-2013, but where do sale rumours leave the company?), the firm has moved to allay fears that its biosimilar rituximab development programme is in trouble (rituximab is marketed by Roche as Rituxan, primarily for the treatment of non-Hodgkin’s lymphoma).

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There were suggestions on Wednesday that Celltrion had quietly shelved development of the rituximab biosimilar, but the company released a statement on Thursday to confirm that Phase III studies remain set to commence later in 2013.

While existing documentation suggests that Celltrion had always planned to progress its rituximab biosimilar programme (CT-P10) into Phase III studies later this year, following the successful completion of a 147-patient Phase I trial, the EU Clinical Trials Register shows that studies being undertaken in Hungary, Greece and Spain have been prematurely ended.

Although Celltrion suggests that Phase III studies will be initiated later this year some confusion remains. Asthika Goonewardene – a healthcare analyst at Bloomberg Industries – told FirstWord "it makes little sense why then the clinical trial register reads 'prematurely ended,' unless they are completely scrapping this entry and coming up with a new trial structure."

Both Teva/Lonza and Samsung have announced setbacks in their pursuit of biosimilar rituximab since October last year (see ViewPoints: Teva hits delay in pursuit of biosimilar Rituxan and ViewPoints: Samsung's biosimilars bullishness hits a setback), with Teva/Lonza stating that delays would be caused by a reassessment of trial structure. Goonewardene notes that development of Teva/Lonza’s product remains in limbo, thus some scepticism towards Celltrion’s own Phase III development may remain until a new clinical trial outline is confirmed.

Goonewardene is confident, however, that there is nothing more damaging – such as a safety signal – at play. He points to the ongoing Phase I study, the status of which recently changed from 'recruiting' to 'ongoing, but not recruiting.' The timing of this status change "roughly coincides with the 24-week follow-up required for the last patient recruited, enabling the study to finish close to its August 2013 completion date," added Goonewardene.

Assuming Phase III studies commence late this year, Celltrion appeares positioned to be a third-to-market entrant in the biosimilar rituximab space – behind Novartis' Sandoz unit and Boehringer Ingelheim. Nevertheless, holding an evidently stronger position in the race to bring biosimilar infliximab (Remicade) and trastuzumab (Herceptin) to the market, Celltrion could still chose to re-jig its priorities.

"The company may be under some pressure to contain costs with biosimilar infliximab and trastuzumab progressing rapidly towards market," suggests Goonewardene. Theoretically, he adds, the positive impact of such restructuring on Celltrion's profit and loss account could prove beneficial as the CEO looks to sell his controlling stake.

The key beneficiary if Celltrion's development programme is delayed at all is Roche, which generates around 14 percent of its total revenues from the branded Rituxan franchise. The company has previously referenced setbacks in the biosimilar rituximab space at investor and analyst meetings, which have also been seen as indicative of the broader challenges faced by biosimilar developers.

Roche is not resting on its laurels, however, and is expected to unveil positive data for its Rituxan follow-up GA101 at the ASCO meeting in June (see ViewPoints: Roche looks to stay one step ahead of biosimilar foes). Nor should the company be confident that biosimilar competition will not materialise; Novartis' Sandoz unit remains confident of delivering a first-to-market biosimilar rituximab, while Boehringer Ingelheim also remains an active early-mover player. See ViewPoints: Novartis remains bullish on biosimilars and Spotlight On: Boehringer Ingelheim's rituximab revelation illustrates evolving biosimilars landscape.

Further recent biosimilars analysis:

ViewPoints: Branded biologic manufacturers buoyed by state legislation in US biosimilars fight

ViewPoints: AbbVie's EMA data injunction – biosimilar defence strategy?

ViewPoints: Sanofi sees no conflict in marketing biosimilar insulins alongside branded Lantus

ViewPoints: Roche CEO Schwan – Biosimilars part of pharma's "contract with society"

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