Biosimilar drugs get boost as UK cost agency backs their use

Cheaper "biosimilar" copies of expensive biotech drugs received a boost in Britain on Tuesday when the country's health cost-effectiveness agency NICE said patients needing such medicines "should be started with the least expensive drug."

So-called biosimilars are gaining ground in Europe, which has been faster to adopt their use than the United States, offering savings to healthcare systems and threatening sales of companies making original products.

The latest ruling by the National Institute for Health and Care Excellence (NICE) is a further victory for the biosimilar lobby and may help two cheaper copies win market share from five other original brands.

Pfizer unit Hospira and Napp Pharmaceuticals both offer biosimilar treatments for rheumatoid arthritis, known as Inflectra and Remsima, that are copies of Merck and Johnson & Johnson's established blockbuster Remicade.

These have now been recommended for use on the state health service, alongside Remicade. However, Remicade is at a cost disadvantage since it has a list price of 419.62 pounds ($598) per 100 mg vial, against 377.66 pounds for the two biosimilars, and NICE said negotiated prices for the biosimilars were even lower.

The other four drugs endorsed for use on the state health service in the final updated guidance from NICE are AbbVie's Humira, Pfizer's Enbrel, UCB's Cimzia and Bristol-Myers Squibb's Orencia.

These four drugs are more expensive on an annual basis than the biosimilars, according to NICE.

The potential for biosimilars to win business from pricey original brands is not only a focus for healthcare providers but also a growing concern for investors, worried about the impact on large drug company earnings.

A growing number of biosimilar versions of top-selling biotech medicines are set to reach the market in the next few years, although the scale of their impact is unclear as they represent a new type of medicine.

Because biotech drugs are made from living cells it is impossible to manufacture exact copies, as happens with simple chemical medicines, so regulators have come up with the notion of approving products that are similar enough to do the job.

Uptake of biosimilars is therefore dependent on how healthcare systems and doctors view their reliability.

A copy of Enbrel from South Korean company Samsung Bioepis was also approved for sale in Europe earlier this month.

($1 = 0.7017 pounds) (Editing by Mark Potter)