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CANMab gains approval in India: Another interesting turn for trastuzumab
With the recent announcement from Mylan and Biocon that their non-innovator biologic version of Herceptin has received approval in India for the treatment of HER2+ metastatic breast cancer, the story of trastuzumab has taken another interesting turn in that country. The approval of CANMAb, as the product will be known, marks the entry of the first non-innovator biologic of Herceptin in India, while Roche's rituximab has faced competition there from Dr. Reddy's Reditux since 2007. What makes this case particularly interesting, however, is the fact that Roche, through a tie-up with domestic firm Emcure, has already brought an "auto-biosimilar" Herceptin of sorts to the market. Under the terms of this partnership, which also applies to rituximab, Emcure has been repackaging the Roche drug under the brand name Biceltis since August 2012. This aspect clearly changes the nature of the game for CANMAb.
The Indian context Historically, Roche has faced pressure from regulators in India to reduce prices, mainly through the threat of compulsory licensing. It is claimed that trastuzumab was first made available in India at a price of INR1 lakh (approx. USD2,031.02) per vial. Since that time, up to and including entry into partnership with Emcure, the company has sequentially lowered the price, reportedly reaching a reduction of around 33% of the 2011 price. Given this context, it will be interesting to see what strategy is employed for CANMAb. While something like a 30-40% discount over the price of an originator might be considered a typical pricing strategy for a first-entry non-innovator biologic in India, the parameters have clearly changed as a result of Roche's pre-emptive move.
The Indian market for HER2+ metastatic breast cancer is a large one; stakeholders estimate that around 5% of women who require treatment with trastuzumab currently have access to the therapy. If competition sparks a market creation effect - which occurred quite dramatically in the case of Reditux entry in the rituximab space - then there may be room in the market for a number of players. Going forward, and especially once additional entrants hit the market, we may expect to see emphasis placed on patient support schemes as a means to promote access.
Going further afield Meanwhile, for the emerging generation of non-innovator monoclonal antibodies, there is the interesting issue of definitions to be considered. In India's case, 2012 saw the introduction of the new Guidelines on Similar Biologics, which have formalised the country's approval pathway for non-innovator biologics for the first time. As these guidelines require demonstration of similarity in physicochemical characteristics as well as safety and efficacy to an authorised reference biologic, some would contend that products approved under them should qualify as biosimilars. The issue becomes a bit more complex when one considers products whose development programmes were already under way when these guidelines were published -although they may have been formally approved since their implementation.
In any case, it may not be long before we see an "India first" strategy - that is, initial launch in the Indian market, bringing the benefits of a large population from which to acquire real-world data, to support subsequent filing in developed markets. Our research has certainly revealed that there are a number of players in the non-innovator/biosimilar monoclonal antibody space in India, some with ambitions for going further afield.
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