Roche : Well-equipped to face rituximab biosimilars
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One of the very first objectives of the meeting with Prof. Dreyfus was to assess the value and strength of the rituximab franchise. Although there is no doubt that the adoption of a biosimilar will be fast once approved, Roche will benefit from significant growth by then and also beyond with the subcutaneous formulation and with GA-101.
As we start considering the rituximab franchise, it is worth saying that rituximab per se is still very much alive and growing! Prof. Dreyfus was clear in reporting that the drug was still expanding its scope of indications mainly as a maintenance therapy in mantle-cell lymphoma and in CLL. This is a very significant additional opportunity to present revenues.
However, the whole rituximab franchise would be jeopardised if and when a biosimilar is approved which in Europe could happen as early as late in 2013. And Prof. Dreyfus stresses he would not even be consulted before a switch is operated as the hospital pharmacist is the one who decides. As with EPOs, it is going to be a massive conversion.
Roche has recently implemented a couple of initiatives to protect the drug above and beyond the RA indication (which is not addressed here). The first one which is likely not to be fully captured is a subcutaneous formulation which will have two advantages: (i) be a positive answer to patients’ wish to stay at home for their treatment as long and as often as possible; and (ii) reduce the cost burden of a hospital stay in a very meaningful manner. Phase III data should be unveiled in the course of 2012. Last and not least is GA-101, obviously a new-generation product that could eventually replace rituximab as a more potent and safer agent. Response rates were encouraging in some very advanced and aggressive lymphomas. Prof. Dreyfus confirmed that Roche had high hopes with the drug that it wants to move forward as quickly as possible. If successful, first filings would happen next year in the first indications.