Regulators must be given ways to approve follow-on 'biosimilars' when proteins fall out of patent if the fruits of molecular biology are to have the greatest possible effect on health care.
Late last month, the European Commission granted marketing authorizations to three companies for generic versions, or 'biosimilars', of the hormone erythropoietin. Amgen, the world's largest biotechnology company by sales, started selling Epogen ('Epo'), its recombinant version of this naturally occurring hormone, in 1989, producing it from cells into which the relevant gene had been engineered. The drug's ability to boost red blood-cell production has led to its widespread use to treat the anaemia associated with some diseases. Epogen and its newer incarnation, Aranesp, earned nearly US$7 billion for Amgen last year, and more than $3 billion for Johnson & Johnson, which has licensed the drug from Amgen and markets it in the United States, Europe and elsewhere. Now that the commission has allowed other companies to market their own version, revenues from Johnson & Johnson's estimated 250,000 European customers look set to erode. Sandoz, the generic-drugs branch of Novartis, said on 10 September that it will have its version of the drug on the market in the United Kingdom and Germany as soon as October, and that it will cost 25–30% less than Johnson & Johnson is charging.
The approvals bring to five the number of follow-on biological drugs to which the commission has given the go-ahead since it opened up a regulatory path for their approval last year. Eleven more applications are in a lengthening queue at the European Agency for the Evaluation of Medicinal Products. In the United States, though, the situation is very different. When the US patents on Epo expire, Amgen will not, as things stand now, face any new competition. The US Food and Drug Administration (FDA) doesn't have the authority to designate subsequent versions of biologicals — drugs consisting of proteins made using biotechnology — as interchangeable with currently marketed products. The potential for such products is large (see News Feature, page 274); sales of biological drugs no longer protected by patents in the United States were worth $11.5 billion in 2006. But at the moment the United States does not have an abbreviated regulatory system for biosimilars, which seek simply to mimic the drugs already on sale, so — with rare exceptions — there is no way into that market.
This year Congress vowed to put this matter right. A bill drafted by leading liberal Democrats and conservative Republicans in the Senate and backed by the Senate health committee would give biotech companies twelve years of market exclusivity on any new biological drug from the time that it is approved. This is longer than they might get from patent protection alone, which starts to run out as soon as the patent is granted even if the drug has not been approved. Companies with an interest in making biosimilars would, for their part, receive an abbreviated pathway to FDA approval of their follow-on products once that twelve-year period is up.
But neither the generics industry nor the biotech industry seem to be pushing to have this compromise passed by the House. Why? Because, compromise that it is, neither side is entirely happy. The generics industry is assuming that it will get a better deal in 2009, under a new US president. The biotech industry, although willing to stomach the compromise, is not going to go to bat for it. And so American health-care providers will continue to pay exorbitant prices for drugs such as Genentech's Cerezyme (imiglucerase) for Gaucher's disease, which is off patent but still costs up to $200,000 per patient per year. The US biotech industry will continue to operate under a cloud of uncertainty that does not hamper its European competitors.
No one is suggesting that biosimilars will ever be marketed with the large discounts — 70% or more — that consumers enjoy when they buy generic versions of small-molecule drugs. But given current prices, regulation that facilitates generic competition on pricey biologicals while duly protecting innovators would still help health-care providers greatly. It's fair, it's possible, and Congress should make it happen now.
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Drug Discovery Today (2009)