According to a story in Fierce Biotech, now that the EMA has published guidelines for how it plans to review biosimilar applications, we could be in for a stampede charge of applications by the largest biosimilar competitors like Novartis (Sandoz), Teva and Hospira. With Roche's Rituxan, Herceptin and Avastin coming off patent, these top selling drugs look like inviting targets. The Financial Times says that the first competitive products could be seen as early as 2012.
Merck KGaA (Erbitux), J&J (Remicade) and Abbott (Humira) could also face competition in the relative near term (though later than the Roche products). Roche for its part wants regulators to be cautious and slow.
"We believe that patient safety must be of the highest concern when evaluating the development, approval and marketing of biosimilar products"
Posted by Bruce Lehr November 30th 2010.