Celltrion’s biosimilar drug Remsima, a lower-cost replica of Johnson & Johnson’s (J&J) top-selling drug Remicade, is expected to be launched soon in the U.S.
The review committee of the U.S. Food and Drug Administration (FDA) gave a thumbs-up to the authorization of Remsima’s access to the US market on Feb. 9. If the FDA offers the final approval this coming April, Remsima will become not only the first Korea’s homegrown biosimilar drug to gain a foothold in the U.S., but also become the world’s first Remicade biosimilar introduced to U.S. market. Remicade is J&J’s top-selling biologic drug for immune system disorders including arthritis and Crohn’s disease.
The U.S. market accounts for roughly 54.5 percent of the global market enjoyed by the original drug, Remicade, and is estimated at roughly 10 trillion won (US$ 8,591 million). Celltrion’s bisimilar, already being sold in 67 countries, could take a bite out of the market once it wins FDA certification.
Usually, a positive recommendation delivered by an FDA advisory committee at this stage is typically followed by subsequent legal approval weeks later. Consisting of 24 experts, the FDA Advisory Committee is an FDA expert body that provides a comprehensive opinion on effectiveness of treatment, safety and price affordability. The committee reportedly recommended the biosimilar sales in the state side based on comparisons between Celltrion’s Remsima and the U.S. original product, Remicade. Concluding that the data submitted by Celltrion demonstrates that Remsima is highly similar to the original Remicade, the committee recommended the sales approval of Celltrion’s Remsima by a majority of 21 to 3.
Although Remsima was launched in European markets in February last year and is now sold in 40 countries worldwide, the U.S. market has remained elusive. The regulatory environment for biopharmaceuticals in the U.S. has been known to remain protective of original drug makers with a U.S. origin.
Celltrion applied to the FDA for approval in August 2014, but it took one year and six months for the US authority to convene a committee meeting to review and discuss the approval of Remsima.
Nevertheless, recently U.S. biopharmaceutical regulations show signs of change as the U.S. government seeks to mitigate healthcare costs.
Earlier last year, the U.S. FDA approved its first biosimilar, a copy of Amgen’s Neupogen cancer medicine by Novartis of Switzerland, which signified that the US is finally opening doors to biosimilar drugs after years of lobbying by biopharmaceutical giants.
Since the passage of The Patient Protection and Affordable Care Act (PPACA), commonly called Obamacare, the FDA shifted to a positive stance on biosimilars wile launching guidelines for biosimilar authorization in 2012.
The foreseen introduction of Remsima to the U.S. market at the price of at most 40 percent cheaper than the original is expected to have a dramatic impact on the sales of the original drug, Remicade. A Celltrion insider said the company aims to capture more than 30 percent share of the global market which Remicade is currently enjoying.
After Celltrion’s Remicade biosimilar was approved in Europe in February 2015, J&J saw its second-quarter sales of Remicade outside the U.S. fall to US$580 million last year, compared to US$783 million a year earlier. European doctors reportedly moved to prescribing the cheaper version of the drug.
In the U.S., private insurance companies decide what drugs to prescribe. As insurance companies seek to lower the insurance cost, many expect the bisimilar proportion will grow to 88 percent of the market share of the original medicine once the FDA authorizes access of biosimilars to the market.
After having spent the first five years as a contract manufacturer for other drug makers, Celltrion started to invest in developing its own biosimilar in 2007. Back then, people in the industry thought the timing was too early given the expiry date of U.S. patents on most major biologics being in the late 2010s. Even as it gathered speed for expansion last year, Celltrion suffered a blot on its reputation when its chairman was fined 300 million won (US$ 257,757) for stock price manipulation. Its achievement today seems to be a fruit born out of numerous kinds of struggles the company has gone through.