Large Pharma is discovering it exhausting to maintain up with challenges from biosimilar makers, together with Korean corporations, quickly penetrating the worldwide market dominated by authentic medicine, trade watchers mentioned Friday.

Korean biosimilars are making strong challenges to original drugs in the global market.
Korean biosimilars are making robust challenges to authentic medicine within the world market.

The rheumatoid arthritis remedy market is a working example, the place originals’ gross sales have continued to drop within the face of biosimilars’ robust displaying.

The third-quarter sale of Janssen’s rheumatoid arthritis remedy Remicade (ingredient: infliximab) stood at $761 million, down 12.2 % from the identical interval final 12 months. This 12 months’s cumulative determine additionally remained at $2.42 billion, down 14.8 % from $2.84 billion a 12 months in the past. Within the U.S., the most important marketplace for infliximab remedies globally, Remicade posted gross sales of $2.58 billion, down 18.5 %.

Remicade’s income drop was as a consequence of challenges from Korean biosimilars.

Celltrion and Samsung Bioepis are at present accelerating penetration within the U.S. Remicade market. Celltrion is working with Pfizer to promote Inflectra, and Samsung Bioepis sells Renflexis with Merck, generally known as MSD exterior of the U.S. and Canada.

Inflectra’s market share within the U.S. was 10.7 % on the finish of final 12 months however soared to 22 % in October. It was the primary time a biosimilar had exceeded 20 % share within the Remicade market. Samsung Bioepis’ Renflexis additionally took a market share of seven %. In Europe, Inflectra has surpassed the unique product by taking 53 % of the market share.

In response to Pfizer, Inflectra recorded gross sales of $172 million within the first 9 months, up 6 %. Its cumulative gross sales additionally climbed 3 % to $485 million through the cited interval.

Pfizer’s rheumatoid arthritis remedy Enbrel (ingredient: etanercept) can be shedding its market share due to biosimilar merchandise.

Because the drug confronted competitors from biosimilars within the European market, gross sales fell 12 % within the third quarter of this 12 months to $283 million.

AbbVie has the identical considerations over biosimilars as its flagship product Humira (Ingredient: adalimumab), a rheumatoid arthritis remedy, is going through robust challenges from biosimilars.

Humira has accounted for about half of the corporate’s complete gross sales with $19.83 billion final 12 months. Within the first three quarters of this 12 months, it recorded $15.36, a 4.6 % enhance 12 months on 12 months.

The issue, nonetheless, is the U.S. market.

Humira’s patent expires in 2023 within the U.S. market, accounting for greater than 80 % of its world gross sales.

It stays to be seen whether or not Humira, the most important blockbuster drug within the world marketplace for years, will be capable of repel the gross sales offensive by biosimilars after the patent’s expiry, in response to market watchers.

Humira performances in Europe again up such considerations. Its European gross sales plummeted in 2019 because of the launch of a biosimilar following the expiry of patents. Final 12 months, Humira’s gross sales exterior the U.S. dropped 12.5 % to $3.72 billion. Within the first 9 months of 2012, its worldwide gross sales besides America fell to $2.57 billion.

Humira’s opponents embrace Samsung Bioepis’ Imraldi, Amgen’s Amjevita, Sandoz’s Hyrimoz, and Mylan and Fujifilm Kyowa Kirin’s Hulio.

Amongst them, Samsung Imraldi’s progress is steep. In response to its accomplice Biogen, Imraldi’s gross sales totaled $216.3 million final 12 months, up 17.6 % from 2019. The biosimilar additionally recorded $170.9 million in gross sales within the first 9 months of 2021, up 5.1 %.

AbbVie could even need to brace up for worse conditions as a result of Humira’s sakes are anticipated to fall additional because the drug’s patent is about to run out within the U.S. in 2023, in response to the market sources.

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