Competition of Humira biosimilars intensifies

Samsung Bioepis' Adaloche released early next year, and Humira's Similar Competition intensifies

Humira

Celltrion and LG Chem compete in earnest in the biosimilar market of Humira (Adalimumab).

 

Both companies have completed phase III clinical trials and are currently working on preliminary work to apply for product approval.

 

If Samsung Bioepis, which has already obtained approval for the product, releases its product early next year, competition in the Humira biosimilar market with annual sales approaching ₩100 billion will intensify.

 

According to the pharmaceutical industry on the 12th, Celltrion is in the process of preliminary work to apply for an item license for CT-P17.

 

CT-P17 is a Humira biosimilar being developed by Celltrion.

 

Celltrion has conducted phase I and III clinical trials simultaneously in the United States, Europe, and Korea since March last year.

 

It applied for an item license in Europe in this March.

 

According to industry officials, the application for a domestic item license is also imminent along this extension.

 

An official from Celltrion said, "After the clinical trial was completed at the end of last year, we are currently in the process of preliminary work for domestic item license application, but we have not yet determined the exact time to apply for approval." According to Celltrion, CT-P17 is the first high-concentration formulation among Humira biosimilars.

 

The dose was reduced from the previous 4 times to 2 tims.

 

It is evaluated for improving patient convenience by removing citrate, which may cause pain during self-injection.

 

LG Chem is also preparing to apply for a Humira biosimilar product license.

 

LG Chem is developing a Humira biosimilar named LBAL.

 

Since 2016, it has conducted phase III clinical trials simultaneously in Korea and Japan with Japanese pharmaceutical company, Mochida.

 

The clinical end point is in the first half of 2018, ahead of Celltrion.

 

LG Chem is preparing for product approval based on the clinical results.

 

An official at LG Chem said, "We are preparing additional data for product approval after the 3rd phase of clinical trials is completed." LG Chem's LBAL is characterized by changing the composition of the protein formulation by different combinations of various additives so that it can be stored more stably than existing products for a long time.

 

LG Chem has applied for a related patent earlier this month.

 

Prior to the two companies, Samsung Bioepis has obtained product approval from Humira Biosimilar.

 

In September 2017, Samsung obtained a license for 'Adaloche' in the form of a injection.

 

Pen-type injections was approved in July of this year.

 

However, this product has not been released in earnest yet.

 

The official release is scheduled for early next year due to a license agreement with the original company, AbbVie.

 

If Celltrion and LG Chem succeed in obtaining product licenses for Humira biosimilars, three companies are expected to form a competitive structure in the domestic market together with Samsung Bioepis.

 

In particular, Humira is expected to intensify competition as it is the item that generates the most sales among various autoimmune disease treatments.

 

According to IQVIA, Humira's domestic sales last year were ₩96.2 billion.

 

In Europe, where competition for the Humira biosimilar market began before Korea, biosimilars are targeting the original very quickly.

 

In Europe, Samsung Bioepis, Amgen, Boehringer Ingelheim, Sandoz, Pfizer, and Mylan have each released Humira biosimilars.

 

An official from the pharmaceutical industry predicted that "Celltrion will be able to obtain a license as early as the first half of next year.

 

If LG Chem adds to this, competition in the domestic Humira biosimilar market will begin in earnest from next year."