April 27, 2024

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Biosimilars refer to cheaper, near-replicas of live cell biologic drugs that have lost patent protection. Many drugmakers have taken to developing these lower-cost alternative drugs in time for the patent expiry of some of the world’s top-selling medications.

Pfizer said its biosimilars business led by Inflectra recorded a robust 62 percent operational growth in the first quarter to offset the falling revenues of its flagship “essential health” division products, such as antidepressant Pristiq and anti-epileptic drug Lyrica.

On the other hand, sales of Remicade in the US appear to have fallen, though by a small margin for now, presumably due to the introduction of the biosimilar. J&J’s Remicade sales in the US fell 2.4 percent to $1.18 billion in the first quarter, according to the firm’s quarterly earnings announced last month.

Meanwhile, Remsima appears to be expanding its market share in Europe, a region where biosimilars were long approved and are therefore prescribed more readily in comparison to the US.

Celltrion said that Remsima, introduced to the region in 2014, has taken away more than 40 percent of the original drug’s market in Europe as of now, quoting the latest data compiled by IMS Health.

Merck & Co., also known as MSD internationally, which handles the sales of Remicade on behalf of J&J in Europe, reported that the blockbuster drug’s sales fell 34 percent on-year to $229 million in the first quarter.

MSD cited the drop in Remicade’s sales in the region to continued competition with biosimilars.

Celltrion said it expects Remsima’s sales to continually expand in the coming months as it continues to eat into a bigger portion of the original drug’s sales in the US and Europe.

Remsima, currently the only Remicade-referencing biosimilar available in the US, is expected to retain its exclusive status in the country for a year or so, the Korean drugmaker said.

Last month, the US Food and Drug Administration approved the second Remicade-referencing biosimilar, developed by Korea’s Samsung Bioepis.

However, sales of Samsung’s Remicade biosimilar will not begin until late this year, as companies are required to wait 180 days after approval to begin selling a biosimilar, according to US regulations governing the new biologic drug category.

Moreover, Celltrion said it will take additional time for the competing Remicade biosimilar to formally arrive at hospitals in the US, as it will have to clear pricing negotiations and get through the procedures to be listed on the country’s health insurance system.

“Given this, Remsima is forecast to retain its exclusivity in the US market for around one year or so,” Celltrion said in a statement. 

“We expect Remsima to quickly drive up its market share in the US quarter by quarter, as it did in Europe,” the company said, noting that it is currently wrapping up procedures to register its cheaper infliximab drug into the national and private health insurance system in the US.

By Sohn Ji-young/The Korea Herald (jys@heraldcorp.com)