Despite delays by the FDA and some opposition from originator companies, biosimilars now represent one of the most rapidly evolving areas of product development in the biopharmaceutical industry. Amgen’s Enbrel had been talked about as one of the first complex biologics likely to appear in a biosimilar form, with protection assumed to expire in late 2012 in the U.S. and in 2015 in Europe. On November 22, however, Amgen reported that a patent for the fusion protein that is Enbrel had just been extended by 17 years. Biosimilar companies with large stakes in antibody development, however, are still likely to challenge the ’182 patent or come up with ways to circumvent it. Who do you think will succeed?
Will Amgen be able to defend against the incursions of biosimilar competitors for Enbrel?