바이오스펙테이터

by Jongwon Jang

biosimilars(Humira·Herceptin·Rituxan·Remicade) drive into European market, while competition of Remicade in American market intensified.

The presence of domestic biosimilars in the global market is ever-intensifying. This is due to the ongoing expansion of domestic biosimilars, such as Humira, Herceptin, and Rituxan, as well as the well-known Remicade and Enbrel into the domains of other block-buster markets of bio-pharmaceuticals. In particular, biosimilars of Celltrion and Samsung Bioepis are expanding influence in the European market. The sales records of 2018, announced by global pharmaceutical companies, reflect the advancement of domestic biosimilars.

◇ Imraldi of Samsung Bioepis Seized the Initiative in the Battle of biosimilars for Humira in the European Market

Upon expiry of the patent rights of Humira (main substance: Adalimumab) last October in the European market, the biosimilars, such as Imraldi of Samsung Bioepis, Amgevita (Amgen), Hyrimoz (Sandoz), and Hulio (Mylan and Fujifilm Kyowa Kirin Biologics), started competition to secure market share therein by releasing biosimilar products. Currently, the Imraldi of Samsung Bioepis seems to be seizing the initiative of competition.

According to the announcement of sales records of Biogen, which is the European marketing partner of Samsung Bioepis, Imraldi recorded sales amount of 16.7 million USD (19 billion KRW) during the 4th quarter last year, which was the first quarter of product release. The records resulted from two and a half month sales from the release of Imraldi last mid-October.

Imraldi was the only one among its competitors to open its sales records. Amgen announced aggregated sales amount of 34 million USD for the 4th quarter for Amgevita and Kanjinti (released last May), the biosimilar of Herceptin. While the ratio of Amgenta is estimated to be small, by taking account of Kanjinti, released last May, 21 million USD in sales were recorded during the second and third quarters, and these sales are expected to show an increasing trend. According to IQVIA, the market research institute, Imraldi occupied 60 % of the European market share of biosimilars for Humira at the end of last December.

◇ Roche recorded Sales Amount Decreased by the Advancement of biosimilars of Rituxan and Herceptin

biosimilar of Rituxan (main substance: Rituximab), the Truxima, developed by Celltrion, is propagating in the European market since it was launched in April 2017 in the United Kingdom. According to IQVIA, Truxima recorded 35 % of European market share in the third quarter last year. In particular, it recorded higher market share of 36 % in the major 5 countries comprising the United Kingdom (66 %), France (42 %), and Italy (31 %).

The correctly aggregated sales amounts of the biosimilars were not counted, due to the distribution of biosimilars by diverse pharmaceutical companies. However, the sales records of Roche, which is currently supplying Rituxan to European countries, shows signs of sales increase of Truxima. The sales amount of Roche has decreased by 4 % to 916 million fr. (approximately 1,030 billion KRW), compared with that of the previous year. In contrast, the market in the USA, into which the biosimilars were not released, the sales amount of Rituxan recorded 4 % increase to 4,290 million fr. (approximately 4,830 billion KRW), compared with that of the previous year. This suggests the invasion of Truxima in the European market that threatens Rituxan.

Herceptin (main substance: Trastuzumab) faces a situation that is similar to that of Rituxan. Roche recorded a 16 % decrease in sales amount to 1,849 million fr. (approximately 2,080 billion KRW), compared with that of previous year. Dramatic consequences of sales records appear in quarters wherein, compared to 3 % decrease in the sales amount of 551 million fr. of the first quarter, the rapid decrease in sales amount of 525 million fr. (7 % decrease in the second quarter), 419 million fr. (21 % decrease in the third quarter), and 354 million fr. (34 % decrease in the fourth quarter), appeared. Ontruzant of Samsung Bioepis was released into the European market in March, whereas the Herzuma of Celltrion was released in May.

Celltrion opened 6 % of the European market share of its product during the last three quarters, which was reported by the market research institute. However, Merck in the USA, which is the sales agent of Ontruzant in the European market, does not reveal separate sales records of biosimilars.

◇ Remsima and Benepali Swept over the European Market for Similars of Remicade

Remsima of Celltrion (main substance: Infliximab) and Benepali (main substance: Etanercept) of Samsung Bioepis have already swept over the European market. According to IQVIA, Remsima exceeded the share of original medicine with 55 % of European market share in the third quarter last year. The sales amount of Remsima, reflected in the sales records of Pfizer, which is the one of the sales agents of Remsima in the European market, marked 22 % increase to 319 million USD, compared with that of previous year. Flixabi of Samsung Bioepis also recorded approximately 380 % of sales increase from (9 to 43.2) million USD.

In contrast, the sales of Remicade of Merck, USA, decreased by 30.5 % last year to 582 million USD. Sales amount of Remicade recorded consecutive decrease over 30 % for two years, following the previous year’s decrease of 34 %. Benepali of Samsung Bioepis recorded 485 million USD last year in the European market (counted by Biogen), and showed 30.9 % increase in sales, compared with that of 371 million USD. In contrast, the sales of Enbrel in the European market by Pfizer decreased by 18.3 % from 1,410 million USD (previous year) to 1,152 million USD. According to IQVIA, Benepali occupies 40 % of the share of the entire market of Enbrel in Europe.

◇ Challenge for the American Market of Domestic biosimilars is in Progress

The barrier to the biggest market of biosimilars in the US market is still high. The complex structure of distribution and diverse policies of discount, and the frequent civil suits and litigation have prevented pharmaceutical companies from making inroads into the market, which has slowed down the speed of infiltration.

Pfizer officially announced 259 million USD (290 billion KRW) of sales of Remsima in the USA market last year. This corresponds to 119.5 % increase in sales, compared with that of the previous year of 118 million USD. Pfizer has been supplying Remsima of Celltrion exclusively to the US market since December 2016. After recording 4 million USD in sales in the first year, Remsima has been recorded two digit increase in sales every quarter; however, it recorded minor decrease of 70 million USD in the 4th quarter last year, compared with that of 71 million USD in the previous quarter. Merck of the USA does not reveal the sales amount of Renflexis, the biosimilar of Samsung Bioepis.

In contrast, Remicade, the original medicine of the biosimilar of Johnson & Johnson, recorded sales amount of 3,664 million USD last year; this corresponds to 19.0 % decrease compared with 4,525 million USD of sales amount in the previous year. A definite decreasing trend in the sales of Remicade appeared; however, the decrease in market share did not appear as was shown in Europe. Along with the approval and invasion of domestic biosimilars led by Remsima and Renflexis accompanied by Truxima, Herzuma, and Ontruzant etc., the market share of original medicine is expected to be replaced with biosimilar in the mid- or long-term future.