The recent spate of setbacks and delays in the biosimilar rituximab space should not be viewed exclusively as a positive development for branded players, note analysts at Barclays in a new report. Moves by biosimilar players to re-jig pivotal-stage trials are driven in part by an acceleration in regulatory momentum, they argue.
Insight, Analysis & Opinion
The rituximab development space has undergone significant ebb and flow over the past year, with Teva and Samsung both suspending clinical trials in 2012. Most recently, Celltrion has accepted a 12-month delay to restructure its Phase III studies, which will now comprise a three-arm trial in rheumatoid arthritis, comparing its biosimilar product to branded Rituxan sourced from both the EU and US. Echoing FirstWord's own coverage, Celltrion appears to be implementing a similar strategy to Pfizer and Boehringer Ingelheim, note analysts at Barclays. See Spotlight On: Pursuit of biosimilar Rituxan hots up as Celltrion confirms new Phase III study/Trial design in biosimilars space comes to the fore in developed markets.
Such a redesign appears at first glance a positive development for Roche, suggest Barclays, but in effect demonstrates not only increased momentum on the part of regulators, but a potential route for interchangeable biosimilars facilitated by the FDA, they add. Furthermore, the perception that biosimilar rituximab developers are struggling is not an accurate one; Barclays suggests that while Celltrion's own programme has undergone a (proactively-induced) delay, Novartis' Sandoz unit should be ready to submit its biosimilar during the second half of 2014, with Pfizer and Boehringer potentially in a position to file in 2015. Dr. Reddy's – which already markets the biosimilar Reditux in India – is also working with Merck KGaA's Serono unit on trials designed to support approval in Europe. See ViewPoints: Dr Reddy's Reditux continues to spur the biosimilar debate as Roche looks to further cut price of Rituxan and Herceptin in Indian market.
Although intellectual property exclusivity is expected to prevent biosimilar rituximab launches in the US from occurring until 2018, it is the emergent role of the FDA that will prove most troublesome to branded players, note analysts. They reiterate the view that revisions to Celltrion's programme reflect discussions with the FDA, and thus indicate that not only are a number of biosimilar rituximab products now well positioned for regulatory submission, but that the US regulator is rapidly gaining ground on its European counterpart regarding a number of key biosimilar issues, including interchangeability.
Analysts at Barclays state that they expect the FDA to follow the recent European directive where each biosimilar has a unique brand name to ensure traceability, but the same International Non-proprietary Name (INN), which would make substitution easier (see Physician Views Poll Results – Substitutable, branded products to win in US oncology biosimilars space). In Europe, suggest Barclays, the European Medicines Agency's Committee for Medicinal Products for Human Use is considering the acceptance of non-inferiority trials that would reduce both the cost and size of clinical development. This suggests that Europe is also learning from the FDA, which has demonstrated more progressive focus on early analytical characterisation.
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