Remsima SC is the idea of ​​CEO Jung-jin Seo

[ECCO 2020 International Society] Closed on 15th, focus on advanced Remsima

'Biobetter' concept establishment between new drug and biosimilar

View of the ECCO 2020 venue

[Vienna, Austria=Reporter An, Kyung-Jin] On the 15th (local time), the annual meeting of the European Crohn's Disease Colitis Association (ECCO 2020) completed a four-day campaign.

 

The ECCO 2020 Conference, which marks the 15th anniversary of this year, was a place to realize that K-Bio's technology has taken a step up.

 

The launch of the first subcutaneous injection (SC) formulated biosimilar with the Infliximab has attracted the attention of attendees as local release and event timing fit exquisitely.

 

There has also been an active debate about whether biopharmaceuticals modified with only the same ingredient should be interpreted as a biobetter.

 

◆The development of Remsima SC was the CEO’s idea.

 

it was lucky

Sung-Hyun Kim, Clinical Planning Team, Celltrion

→Seong-hyun Kim, Celltrion's clinical planning manager, met at the ECCO 2020 conference site and said that chairman Seo Jung-jin is the key to success in developing the world's first subcutaneous injection (SC) with Infliximab.

 

Kim, who met at the Celltrion Healthcare booth on the 14th (local time), is not aware of the question whether there is a company developing a Remsima SC competitive drug.

 

The president’s ideas helped to begin clinical development, with good timing and luck.

 

Jung-jin Seo, who is attached to the next pipeline, frequently meets with local medical staff in Europe.

 

He ordered a development review after hearing the need for subcutaneous injection from nurses who used Remicade.

 

Kim said, "There is a lot of opinion that Remicade is good in the medical field, but there is only intravenous injection type, so convenience is low.

 

It is hoped that the emergence of subcutaneous drugs will completely change the perception of the disease".

 

Also added, “The process was painful, but the results were good.

 

We are waiting for feedback on the 15th of last month with the European Medicines Agency (EMA) completing the application for the Remsima SC indication”.

 

◆Remsima SC is a biobetter?

 

it is Innovative Inflixmab A variety of questions have been asked when the expectation is that Infliximab subcutaneous injections can be introduced in the field of inflammatory growth disease (IBD), which is popular among young people in their 30s and 40s.

 

As a key topic, the issue of how to approach Remsima SC, which only changed the route of administration of Remsima, between a new drug and a biosimilar, emerged as a key topic.

 

Prof.

 

Shomron Ben-Horin named top 10 research

Prof.

 

Shomron Ben-Horin (Tel Aviv University Sheba Medical Center, Israel) announced ECCO's 'Top 10 Highlights' program.

 

They all agreed that Remsima SC is an advanced drug over biosimilars.

 

It is a response to the question that whether there is no problem in accepting it as a biobetter when changing the intravenous injection into a subcutaneous injection in the auditorium immediately after the announcement of the clinical results of Remsima SC.

 

The argument was based on the results of a one-year clinical trial of Remsima SC in patients with inflammatory bowel disease.

 

Infliximab was administered to 131 patients with Crohn's disease (CD) and ulcerative colitis (UC).

 

Serum drug concentrations and therapeutic effects were maintained in both groups who received subcutaneous injections from week 6 to 54 and who received subcutaneous injections from intravenous injection at week 30.

 

Foreign reporters from all over the venue were also noticeable

The introduction of Remsima SC has enabled the 'Dual Formulation' strategy of maximizing the effect of the initial intravenous treatment and maintaining the drug effect by administering Remsima SC by patient self-administration without visiting the hospital.

 

After the presentation, Ho-woong Kim, Head of Medical and Marketing Division, Celltrion Healthcare, said, “Since the application for the Remsima SC permit, the term biobetter was first introduced after the regulatory agency raised the need for a new track, not a new drug or a biosimilar.

 

Recently, various terms such as 'value-added medicine' or 'innovative Infliximab' have been used.

 

Although the terminology is different, there is no disagreement about the ultimate improvement over biosimilars".

 

◆Samsung's three biosimilars save EUR 1.8 billion in Europe →At this year's ECCO conference, much data about biosimilars was released.

 

In the years since biosimilars were introduced in Europe, real world data on various clinical cases accumulated at the medical field have been released.

 

Biogen, which is a partner of Samsung Bioepis, is supplying long-term follow-up of patients who have been prescribed biosimilars in Germany, the UK and France.

 

There have been voices that the original drugs and biosimilars were not significantly different in terms of therapeutic effects or safety, and biosimilars were positively evaluated for their financial savings.

 

Pharmaceuticals, insurance companies, and PBMs are competing autonomously, which is different from the US, where entry barriers were high.

 

Early adopters of biosimilars, Europe was a contrary mood.

 

Exhibition booth of Biogen, a partner of Samsung Bioepis

A Biogen official (at the end of 2019), who met at the ECCO 2020 conference booth, was prescribed biosimilars to more than 200,000 patients.

 

The three biosimilars that Biogen sells have saved over €1.8 billion in healthcare costs in Europe.

 

” Biogen has three biosimilars developed by Samsung Bioepis in Europe, including Renflexis (Remicade Biosimilar), Flixabi (Biosimilar) and Imraldi (Humira Biosimilar).

 

Imraldi, which had released an event in October 2018, actually made annual sales of $184 million last year, the first year of its release.

 

It is a self-diagnosis that Amgen, Sandoz and Mylan have released biosimilars at the same time, gaining market leadership with a sharp increase in sales despite the fierce competition.

 

◆Gastroenterologists, waiting in line at 'Remsima SC' clinical booth, it is amazed at how much things have changed

Ho-Woong Kim, Head of Medical Marketing Division, Celltrion Healthcare

→Ho-woong Kim, Celltrion Healthcare Director, Medical & Marketing Division, met at the meeting of ECCO 2020 on May 14 (local time), said that it is amazed at how much things have changed, just a few years ago, it was difficult to get clinical advice, but now it's completely different.

 

Since the positive clinical results of Remsima SC were revealed at the ECCO 2018 conference last year, it is said that interest has increased enough to inquire about participation in the study abroad.

 

Kim said, “Many researchers are curious about the background that the efficacy, immunogenicity and safety have been maintained despite the change in formulation from intravenous injection to subcutaneous injection.

 

and the successful commercialization of high-impact Infliximab subcutaneous injections has received positive reviews”.

 

Celltrion's experience in biosimilar products, such as Remsima and Truxima, has been accumulated for many years.

 

In addition, quality and trust in the company also contributed to the introduction.

 

Kim said that during the event, he had meetings with foreign researchers of the best in the field of inflammatory diseases, from full-time executives to active executives.

 

Researchers willing to participate in the clinical trials lined up and feel their company's status has changed.