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Samsung Bioepis Sees Wide Open Market for Its Trastuzumab


Samsung Bioepis isn't flinching on its trastuzumab biosimilar launch schedule, COVID-19 and 4 other biosimilar competitors notwithstanding, said Sang-Jin Pak, MD, executive vice president of the company's Commercial Division.

The United States market for biosimilars doesn’t always get the respect it deserves, especially when it’s compared with Europe, which has at least a 10-year lead on biosimilar introduction. But for one company that’s moving into this space, there are undeniable advantages to the US market.

Samsung Bioepis in a partnership with Merck is launching its own trastuzumab product, Ontruzant, and conditions for biosimilar uptake in the United States have been improving lately, said Sang-Jin Pak, MD, executive vice president of Samsung Bioepis’ Commercial Division, in an interview with The Center for Biosimilars®.

“If you look at the latest launches, especially in oncology, they actually are quite successful,” he said. “The uptake is steep, and we see that, among both payers and providers and also patients, the acceptance level is increasing significantly, and so we remain very optimistic for the US market.”

The introduction of Ontruzant marks the fifth trastuzumab biosimilar introduced since 2019, but also the third trastuzumab biosimilar introduced just this year, the other recent entrants being from Pfizer and a partnership of Celltrion and Teva. Samsung Bioepis is based in the Republic of Korea.

It may seem like the market has grown very crowded very quickly, and also highly competitive, but the time proximity for all of these launches is so narrow that sales opportunity is still robust, Pak said.

“We believe there is enough room in the market for us to grow, and there’s enough unmet patient need for this life-saving medicine, so we believe we have an important role to play here in the US market,” he said.

Ontruzant was cleared for marketing by the FDA in January of 2019, and with the first competitor to reference Herceptin jumping into the market in July 2019, and the fourth biosimilar trastuzumab arriving in March 2020, there was undeniable pressure on Samsung Bioepis and Merck to get rolling with their commercialization plan as well, but this was a preplanned launch that was not accelerated by any competitor action, Pak said.

Nor did coronavirus disease 2019 (COVID-19) influence the schedule, he said, although, “obviously, COVID-19 is an exceptional time.”

In the United States, Merck is handling the commercialization end of the launch. For that reason, Pak could not speak to the strategy that would be employed to get the product out to providers and patients. But remote access will be part of that effort, as sales representatives across the pharmaceutical industry have been grounded by COVID-19 and forced to utilize other means of getting the product message out, he said.

“In the time of this lockdown, none of the pharma companies can actually do face-to-face meetings. I think all of them have resorted, more or less, to remote technologies. But I cannot comment if this is going to be the case after COVID-19,” Pak said.

COVID-19 has been a well-placed wrench in the works of many engines of commerce, but Samsung Bioepis believes it will be able to fully support the commercialization of its trastuzumab biosimilar. “We’re very proud of our supply continuity because we have a dual-sourcing strategy, and we believe we have enough inventory in order to ensure continued supply, even in times of COVID-19,” Pak said.

Samsung Bioepis has indicated that it intends to market traszuzumab at a 15% discount to Herceptin. With 6 trastuzumabs on the market, including the reference product, The Center for Biosimilars® asked Pak whether the diversity of offerings would make it difficult to sustain an 85%-to-reference price level.

“It’s obviously hard to predict how this will go, but our experience in Europe has shown that with more competition there is also more price competition; so, yes, my expectation would be that prices will go down over time,” he said.

Samsung Bioepis already has 1 biosimilar on the US market—the infliximab product Renflexis. The company also has a bevacizumab biosimilar planned for the United States. The application for that product was accepted by the FDA in November 2019 and a decision is anticipated by the fourth quarter of 2020.

The company aims to bring an adalimumab biosimilar to market. That launch, against AbbVie’s blockbuster Humira, is expected to occur in 2023, at which time as many as 9 adalimumab biosimilars could flood the market. Five of those, including Samsung Bioepis’ Hadlima, have received FDA approval.

An additional product is Eticovo, an etanercept biosimilar to Amgen’s Enbrel. Eticovo got its approval in April 2019, but the launch date is up in the air. “Eticovo is still not decided yet, and I cannot comment further because there’s some legal action ongoing with another etanercept biosimilar (Erelzi, Sandoz) that we are closely monitoring,” Pak said.

Samsung Bioepis was founded in 2012 as a joint venture between Samsung Biologics and Biogen. Biogen is handling commercialization of the Samsung Bioepis’ biosimilars in Europe. It’s an exciting time for the company, Pak said.

“This is the first oncology biosimilar for us, together with our commercialization partner Merck, in the United States, and we believe that we have really, through process innovation and our quality management, developed and manufactured a high quality biosimilar which will help patients gain access to this medicine,” he said.

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