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Standing out in a crowd

Celltrion Healthcare’s Ho-Ung Kim on pricing, market access and regulatory challenges for successfully developing biosimilars

Ho_Ung_KimFrom a slow start the biosimilars space has become a rather crowded one, so much so that some of the later entrants are starting to decide it would be better to invest elsewhere, as they are so far off from having first- or early-mover advantage.

A company with both an early-mover advantage and a successful track record in the area is the Celltrion Group. Founded in 2002 the South Korean firm has been developing biosimilars since 2003 and has since seen its products approved in 79 countries around the world.

PME sat down recently to discuss pricing, market access and regulatory challenges with Ho-Ung Kim, division head of strategy and operations at Celltrion Healthcare, which carries out sales, marketing and distribution activities for the Group’s biosimilars portfolio. He’s been with Celltrion since 2008 and prior to assuming his current role led the Group’s clinical planning and medical affairs department, previously having spent a decade with Sanofi, Schering-Plough and local Korean pharma companies.

From a company perspective, although Celltrion itself is somewhat under-the-radar, the products the company develops - and its deals with Pfizer, Mundipharma and Teva - are increasingly well known. Last year it won the first European and US approvals for a biosimilar version of the blockbuster arthritis treatment Remicade (infliximab), which is marketed under the brand names Remsima and Inflectra. It followed that this year by gaining approval from the European Commission for the world’s first monoclonal antibody biosimilar of MabTera (rituximab), marketed as Truxima.

It’s a track record that makes Ho-Ung ideally placed to shed some light on the challenges Celltrion’s biosimilars faced, firstly in making it through the regulatory pathway and then in establishing themselves on the market.

Early challenges

As an early-mover in a rapidly-developing market, the biggest challenges Celltrion’s biosimilars faced did not come from a lack of regulatory clarity, although the seven-year wait for the EMA’s 2013 biosimilars guidance - then only the second it had published - can’t have made things easy.

Instead Ho-Ung points to a combination of perceptions of biosimilars among stakeholders, where much educational work has been carried out, and where further efforts are still needed. Ho-Ung also said it pointed to the need for research. “A demand for clinical data meant it took much longer [to bring products to market] than we initially estimated,” he explained.

Switching

Once products reached the market Celltrion observed further challenges when it came to persuading physicians to switch patients from originator biologics to their biosimilar equivalents.

This is despite work to study the effects of switching, most notably in the form of the NOR-SWITCH study. Sponsored by the Norwegian government, the study involved nearly 500 patients across some 40 trial sites and was presented at the 2016 UEG Week in Vienna, Austria. It found that swapping from Remicade to a biosimilar version made by Celltrion posed no problems for patients, regardless of the disease for which they were taking the drug. Worsening of the disease was the primary measure in the trial, and this occurred in 26.2% of those who remained on Remicade and 29.6% of those who switched to the biosimilar, a difference that did not reach statistical significance.

Despite having the study results in place, Celltrion hasn’t had an easy time navigating regulatory pathways. Picking out one example, Ho-Ung said: “The EMA are not willing to set up a new guideline for interchangeability.” It’s something he feels has held back the number of patients that could have been switched from Remicade to Celltrion’s biosimilar version in Europe, where it’s sold by Pfizer as Inflectra and by Mundipharma as Remsima.

“But [when it comes] to recruiting patients for switching, we suddenly had a much higher level of resistance. We urge both patients and physicians to really think about the potential savings cost. What a biosimilar has over its [originator] is its cost-effective price. We’re aiming to provide additional data to show this. The pharmacovigilance clinical data is important to increase the level of understanding of biosimilars and this is something we also need to conduct,” Ho-Ung said.

Here Celltrion faced a doubly difficult situation as the products that were being talked about had a very low profile among patients, who would be aware of the idea of generic versions of their medicines, but on the whole have far less knowledge about biologic treatments compared to small molecule drugs, and an exceptionally low awareness of biosimilars.

The company, with its stated mission of ‘providing quality products at affordable prices’, also found an unexpectedly high level of demand for clinical data on its biosimilars, which Ho-Ung said “took much longer than we initially estimated” to satisfy.

Beyond clinical data, pricing is a key differentiator for biosimilars. The firm says replacing the use of Remicade with its biosimilar version in Germany, France, Italy and the UK would provide a total five-year cost saving that could reach over €430m. But Ho-Ung makes it clear that when it comes to pricing, it’s Celltrion’s commercialisation partners that decide what the price should be in their territories.

Long-term strategy

Looking to the future, Ho-Ung outlines an impressive pipeline, with biosimilar versions of a number of other industry blockbusters. Celltrion’s current focus, he said, is immunology and oncology. With biosimilars of Remicade and Mabthera already approved in Europe, the next in line for a licence is likely to be Celltrion’s Herceptin biosimilar - branded as Herzuma, it was submitted to the EMA for approval in November last year. After immunology and oncology, an area in which Celltrion has 10 further biosimilar candidates, Ho-Ung said his company plans to turn to treatments for influenza and rabies.

Looking further into the future Ho-Ung said Celltrion would be willing to join the World Health Organization’s recently announced pilot to extend its prequalification scheme to biosimilars, such as versions of MabThera and Herceptin. “It’s a long-term strategy that aims to provide quality biologics to developing countries, which matches with our mission,” Ho-ung concludes.

Article by
Gemma Jones

is PMGroup's reporter

7th July 2017

From: Sales

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