Samsung Bioepis may have a problem with its biosimilar version of Amgen and Pfizer's blockbuster immunology drug Enbrel--the good kind of problem. The biosim's European launch is going so well that analysts believe more manufacturing capacity may be needed to cope with demand.
Sales of that biosim, Benepali, by Samsung partner Biogen ($BIIB) are rising three times faster than initial forecasts indicated. The med has already captured "significant market share" from the TNF inhibitor brand, which is used to treat immunological diseases such as arthritis and psoriasis, according to the South Korean company. The drug has been launched at discounts of 30% to 35%, depending on the market.
Analysts at Bernstein said this week that the rapid EU uptake could translate into a surprise bonus in Biogen's third-quarter results, but they worry the two partners could struggle to maintain that momentum unless they can ramp up production capacity for the drug.
As it turned out, Biogen reported this morning that sales of Benepali helped its biosimilar franchise hit $31 million in the quarter--twice the amount reported in the prior three-months. The company said the Enbrel biosim has been "gaining share at a rate previously unseen for a biosimilar anti-TNF."
"The challenge will be how to meet market demand with the current constrained manufacturing capacity," Bernstein's analysts said in a research note. At the moment, the biosimilar has to be made in a Biogen facility, with only a certain number of batches allocated for production.
The partners would need additional regulatory approvals if they want to expand Benepali manufacturing into Samsung's flagship biofacility in Incheon, South Korea, they point out.
"The manufacturing constraints are a concern which needs further attention," says Bernstein, although the overall outlook for anti-TNF biosimilars in Europe is rosy. They pointed to the performance of biosimilars of Johnson & Johnson ($JNJ) and Merck & Co's ($MRK) Remicade (infliximab) in Europe.
The introduction of Remicade biosims in the EU seems to have grown the entire market by around 10%-20%, they said. That suggests price reductions are leading to reduced levels of rationing the med by cost-conscious state-funded health systems.
Samsung Bioepis' crosstown rival Celltrion and partner Pfizer ($PFE) were first to market with Remicade clones in Europe, debuting their Remsima/Inflectra products last year. Since then, those drugs have captured around 30%-40% of the EU market, which in turn accounts for around a third of global sales. Bernstein expects that share to exceed 50% before long. Samsung Bioepis joined the fray in the EU last month with the launch of its Flixabi version of Remicade.
So what is happening across the Atlantic in the U.S.? Pfizer has indicated it plans to launch Inflectra in the much larger stateside market next month. In discussions with Bernstein, Celltrion indicated it was unconcerned about the ongoing intellectual property dispute with J&J, over a cell culture patent used in manufacturing the brand, saying they will "appeal repeatedly until the patent expires in 2018." Meanwhile, Samsung Bioepis is still awaiting FDA approval for its Remicade version in the U.S. after filing it in May.
Interestingly, Celltrion says it has no plans to push its biosimilars out in emerging markets in the next four to five years, saying that even in larger markets such as China and India patient spending is too low, the market is too complicated and the authorities' stance on biosimilars too uncertain.
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