Novartis on Monday issued a direct challenge to Roche, Basel, its local rivals by launching into its drug is one of the top products of its competitors, its own version of the clinical trial.
Sandoz, the Novartis subsidiary specialising in “copycat” generic versions of drugs that have lost patent protection, will begin trials on biosimilar rituximab, the blockbuster cancer and rheumatoid arthritis treatment that Roche sells as Rituxan and Mabthera.
Competitive challenges by generics groups to off-patent prescription treatments are common, especially in view of spiralling demand from financially stretched healthcare providers for cheaper alternatives.
But Novartis’s decision will see highly unusual direct competition between the two Swiss pharmaceutical groups, which are among the world’s leaders by sales.
Novartis’s challenge is also surprising as it holds a stake of close to a third in Roche, making it the biggest shareholder in the company after the group’s founding families.
Analysts said that Basel diplomacy and the potential threat to Roche’s earnings had given way to competitive considerations in Novartis’s decision to go ahead with phase II clinical trials – particularly given the race under way among generic manufacturers to develop a biosimilar rituximab medicine.
Last year Israeli group Teva, the world’s biggest generics maker, and Lonza, its Swiss biotechnology specialist, revealed the start of similar clinical studies on biosimilar rituximab.
Roche’s drug is one of the world’s three biggest selling biopharmaceuticals, with sales of SFr6.09bn ($6.3bn) in 2009. Karl-Heinz Koch, analyst at Helvea, the Swiss brokerage, forecast that sales would reach SFr6.3bn this year. European patents on Roche’s product expire around 2015, and 2018 in the USA.
Sandoz has been a leader in developing not just generic versions of relatively simple to copy pills, but also more complex drugs.
Its portfolio now includes three such products, which require significantly more complex certification procedures than conventional pills.
Producing a “bio-similar” Rituxan/Mabthera would mark a major further step in the process, as producing the treatment is more complicated than Sandoz’s existing biosimilars.
The fact that Sandoz has moved to clinical trials indicates confidence in its product, which is being tested initially for rheumatoid arthritis.
“The data suggest that Sandoz’s biosimilar rituximab is highly similar to the reference product, justifying initiation of clinical studies in patients,” the company said.
Roche played down the risk: "We have several years of patent protection. We look forward to things from the U.S. Luo Huasheng the impact of generic drugs is limited, and with our strong pipeline, we are confident to make up."

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