A lineup of blockbuster monoclonal antibodies produced by a group of the world's top biopharma companies are now squarely in the crosshairs of the world's top biosimilar developers.
Last Friday the European Medicines Agency laid out exactly what developers will need to do to gain approvals for follow-on antibody therapies. And Roche, with its lineup of aging cancer therapies like Rituxan, Herceptin and Avastin, was quickly singled out as the most vulnerable to a new lineup of competitive treatments that could hit the European market as early as 2012. The Financial Times also notes that Merck KGaA, Johnson & Johnson ($JNJ) and Abbott ($ABT) also face near-term competition from the biosimilar crowd. GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) are likely to face new competition at a later stage.
Several big outfits like Novartis ($NVS), Teva and Hospira ($HSP) are likely to lead the charge in creating biosimilar versions of the blockbuster antibodies. But it won't be cheap. The research group Collins Stewart has estimated that developers will need to budget $100 million for the kinds of clinical trials that will be required to gain an approval. And once they hit the market, the follow-ons are expected to offer discounts of 10 to 15 percent.
Roche wants regulators to be cautious--and slow. "We believe that patient safety must be of highest concern when evaluating the development, approval and marketing of biosimilar products." In the U.S., the FDA is just beginning the process of laying out the rules for developing biosimilars.