Norway to compare Hospira knockoff with J&J's Remicade to goose biosimilars market

Hospira ($HSP) and its biosimilar partner Celltrion notched a big milestone in September, getting European approval for the first biosimilar of a monoclonal antibody therapy. The EU signed off on their Inflectra, a biosimilar of Johnson & Johnson's ($JNJ) Remicade. But despite the achievement, the partners still face a huge challenge: getting doctors to use the drug.

As Reuters points out, the uptake on biosimilars, drugs that were expected to play a huge part in lowering healthcare costs, has just not been very good. Why? Because doctors are just not as comfortable with these cheaper versions of cell-based drugs as they are with knockoffs of small-molecule drugs. "From all the evidence to date, we don't think there should be any problems but doctors tend to be reluctant," Steinar Madsen, medical director of the Norwegian Medicines Agency, tells Reuters.

And so in hopes of giving the category a boost, Norway intends to fund some trials of its own to prove to the medical profession that biosimilars are as effective as their counterparts. Beginning next year, Norway will start a trial comparing Hospira and Celltrion's Inflectra to its reference product, Remicade, which J&J shares with Merck ($MRK), and which generated more than $2 billion in sales last year in the EU.

The outcome of that effort will be scrutinized closely not only in Europe but in the U.S., where the FDA is still laying its pathway for biosimilar approval. Payers really want to see the market take off because even though the discounts on biosimilars are far less than those for generic pills, they could still save billions and billions of dollars, euros, pounds or yuan. Citing a study done last year, Reuters says biosimilars could slash biologics spending in Europe by as much as €33.4 billion ($45.5 billion) by 2020. Biosimilars of antibody drugs alone could make up two-thirds of that. IMS Health is less enthusiastic in its projections, saying the global market for the biologic copies could range from $11 billion to $25 billion in 2020, which would only be about 4% to 10% of total biologics sales.

One reason doctors in Europe are believed to be less than enthusiastic about biologics so far is that because of biologics' complexity, they are not considered interchangeable copies. Europe's biosimilar approval process, in fact, starts with the premise that there will be differences and expects drugmakers to show that those differences don't matter. But some in the industry hope the U.S. will create stricter guidelines. It might require such complete control over cell lines that the differences are so "insignificant that the two products will be essentially the same," as Bruce Leicher, general counsel and head of government affairs at biologics and biosimilars developer Momenta Pharmaceuticals ($MNTA), explained to FiercePharmaManufacturing earlier this year.

Many companies, including biologics makers, are counting on significant biosimilar sales down the road. Novartis' ($NVS) Sandoz is moving ahead with programs, and Merck, Biogen Idec ($BIIB), Samsung and Mylan ($MYL) are among those with biosimilar programs. In fact, Mylan and its biosimilar partner, India's Biocon, just last month reported they had gotten approval in India to make a copy of Roche's ($RHHBY) cancer med Herceptin. But others have found the going too much. This summer, Teva Pharmaceutical Industries ($TEVA) and Lonza Group pulled the plug on their partnership.

Meanwhile, biologics makers continue to benefit from the slow growth of biosimilars, as Andy Smith, chief investment officer at fund manager Mann Bioinvest, tells Reuters. So far, he says, biosimilars have been nothing but "a mid-summer fly that you have to wave away occasionally but which doesn't actually sting."

- read the Reuters story

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