August 8, 2022

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The 7th adalimumab biosimilar drug: Coherus Yusimry is approved by FDA

The 7th adalimumab biosimilar drug: Coherus Yusimry is approved by FDA



 

 The 7th adalimumab biosimilar drug: Coherus Yusimry is approved by FDA: it will be on market in 2023!

 

Coherus BioSciences recently announced that the U.S. Food and Drug Administration ( FDA ) has approved Yusimry (adalimumab-aqvh, adalimumab, development code: CHS-1420), which is AbbVie’s flagship product Humira (revised).

Merlot, generic name: adalimumab, adalimumab) biosimilar drugs.

Yusimry for all approved indications Humira, comprising: plaque psoriasis, psoriatic arthritis, rheumatoid arthritis , juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcers Colitis.

 

In 2020, Humira is the world’s best-selling prescription drug, with global net income exceeding 19.8 billion U.S. dollars .

The drug is also the best-selling drug in the United States. In 2020, U.S. net sales exceed 16 billion U.S. dollars.

The entire medical ecosystem in the United States has a high demand for high-quality and low-cost Humira biosimilars.

Coherus plans to launch Yusimry in the U.S. market on or after July 1, 2023 in accordance with the terms of the agreement with AbbVie.

 

According to the US FDA biosimilar drug database, up to now, the US FDA has approved a total of 7 adalimumab biosimilar drugs .

In the United States, Humira’s market exclusivity period will end in January 2023.

Prior to this, AbbVie has reached agreements with many pharmaceutical companies on the time to market for adalimumab biosimilar drugs.

According to the terms of the agreement, Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi Biosimilars of adalimumab developed by Momenta, Momenta and Coherus BioSciences are allowed to enter the US market at different time points as early as 2023.

 

In Europe, Humira lost its patent protection on October 16, 2018, and a number of adalimumab biosimilar drugs are currently on the market in Europe.

 

The FDA approved Yusimry based on a comprehensive data package that proves the biological similarity of Yusimry to the reference product Humira.

 

The data includes:

(1) The results of the CHS-1420-02 study, which is a double-blind, randomized, parallel-group, positive-controlled study conducted in 545 patients with moderate to severe chronic plaque psoriasis and compared Yusimry Compared with Humira’s efficacy and safety (including immunogenicity);

(2) the results of the CHS-1420-03 study, which is a double-blind, randomized, single-dose, parallel group study in more than 200 healthy subjects In the development, a single dose of 40mg subcutaneous injection (SC) was administered to compare the relative bioavailability between Yusimry and Humira to confirm the similarity of pharmacokinetics.

 

 

 

Reference:

Coherus Announces U.S. FDA Approval of YUSIMRY™ (adalimumab-aqvh)

The 7th adalimumab biosimilar drug: Coherus Yusimry is approved by FDA

(source:internet, reference only)


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