Source : 'Generics Bulletin'
Samsung Bioepis Co., Ltd. was established nine years ago with just a handful of employees and a faith in biosimilars. Within four years, it had its first product on the market, while in 2020 it grew into a company with sales of more than $1bn and one of the most robust set of products and pipelines in the sector.
So far, the Samsung Group affiliate has had five biosimilar products - etanercept, infliximab, adalimumab, trastuzumab, and bevacizumab - approved and launched in major markets for various oncology and autoimmune indications. In the pipeline are a number of preclinical and clinical programs for a wide range of diseases, including ophthalmological and rare blood disorders.
Samsung Bioepis EVP Sang-Jin Pak
Last year, the company launched Ontruzant (trastuzumab-dttb) in the US and Aybintio (bevacizumab) in Europe and submitted regulatory filings for SB11 (ranibizumab) in Europe and the US. Also initiated were clinical trials for SB15 (aflibercept) and SB16 (denosumab).
In South Korea, its bevacizumab biosimilar was recently approved and a partnership signed with major domestic pharma firm Yuhan Corporation to commercialize adalimumab. ()
Samsung Bioepis also began this February a Phase I trial for SB17, its biosimilar version of ustekinumab, the interleukin-12 and -23-targeting antibody for Crohn's disease, ulcerative colitis and other indications, for which the original product is Janssen Pharmaceutical Cos.'s Stelara. ()
So what are the factors that have contributed to the company's rapid growth? In an interview with Generics Bulletin sister publication Scrip in Seoul, Samsung Bioepis executive vice-president Sang-Jin Pak emphasized a focus on process innovation and supply continuity as two of the keys.
By establishing a robust development platform, as well as continuously improving and innovating processes, the company had been able to develop biosimilars in a short period of time, while maintaining strong quality, he explained. “When we started the biosimilars business, we looked at all the current processes in the biopharma industry – molecule development, manufacturing process development, clinical operations and regulatory science – and found ways to improve them.”
The company sees the maintenance of quality is a very important aspect of process innovation. Given that biologics are produced in living cells, they have the inherent nature to be heterogeneous between different batches of the same product. For both originators and biosimilars, heterogeneity can be allowed to a small degree, but does need to be controlled very tightly.
In addition, ensuring supply continuity has been a crucial factor to help secure access to biologic treatments. “We have geographically diversified our manufacturing and storage sites across three continents [North America, Europe, and Asia] and this ‘near-market’ strategy allows us to rapidly respond to market dynamics,” Pak explained.
The executive noted that "cost leadership" is another key to success, as the biosimilars market globally is seeing intensifying competition and accelerating price erosion. For Samsung Bioepis, “We aim to achieve cost leadership through continuous process/productivity enhancements, a more efficient supply network, and by spreading overhead costs across new markets and new products," he said.
"We have generated positive operating profit since 2019 and we are well positioned to continue to improve our profitability in the coming years through a combination of new launches and operational discipline."
As with other pharma firms, the global COVID-19 pandemic has put a lot of strain on operations, but the company says it is adjusting ways to keep the operation going and stay connected with customers and expects to make good progress this year.
“We are going through pretty tough times as the pandemic is expected to continue this year. Vaccines have started to be rolled out but it is going to take some time to have enough people vaccinated and for everyone to get back to ‘normal’ life," Pak told Scrip. "Restricted movement and limitations in visiting hospitals and clinics would be a challenging factor but we will work hard with our partners to find ways to stay connected with physicians and patients and ensure access to treatments.”
To mitigate potential product shortage risks, the company is working closely with suppliers and vendors to ensure supply continuity. The pandemic can impact their day-to-day operations and workforce, so it communicates with them closely to make sure they have enough staffing, including training for backup.
Also, in terms of logistics, the company has had to come up with mitigation plans in case of flight changes/cancellations that could affect distribution routes, and take into consideration additional lead-times in freight delivery due to the lengthened inspections needed for COVID-19 protocols.
Due to these efforts, the company says it hasn’t experienced any major disruptions in its supply so far, despite the challenges.
Considering that many countries around the world have instituted lock-downs, it has also been more difficult to recruit patients for clinical trials for pipeline products. But Samsung Bioepis noted it managed to complete recruitment for its Phase III program for SB15 (aflibercept) in February within the pre-planned timeline, helped by its clinical operations team.
It worked closely with investigators to monitor recruitment status for each site, apply updates to the overall recruitment strategy, and quickly adjust recruitment targets for each country and site.
“This is an example of our response to COVID-19, where we had to double down on our strength to ensure continuity of clinical, manufacturing, and supply operations to ensure delivery of our medicines to patients. Managing this on a global basis can be very challenging,” Pak conceded.
Disruption to clinical trials is a well-documented side effect of the pandemic, with many trial sponsors and sites dramatically scaling back activities in line with increased hospital burdens, lock-down measures and reduced patient mobility. As many western countries continue to battle second and third waves of infection, the clinical trial ecosystem has been largely insulated from additional mitigation measures.
At a global level, study sponsors have mostly returned to normal activity despite soaring pandemic case numbers, although this belies important trends within key therapy areas and geographies. Even with a full recovery by the end of 2021, many drug developers will still be counting the cost of the lost trials of 2020, according to Informa’s Pharma Intelligence’s recent report, The Lost Trials of 2020 .
Samsung Bioepis says it will continue to work closely with partners to expand access to its treatments in the US, Europe and other countries where it already has a presence. It believes there is an opportunity for greater geographic expansion, as biologic and biosimilar penetration is still relatively modest, but growing quickly, in many parts of the world.
To this end, it has already launched several products in Brazil and forged partnerships in China, and is evaluating additional markets to extend the geographic reach of its products.
In the long run, as one of the two biopharma pillars of Samsung Group, it aims to become a fully integrated biopharma firm and will continue to evaluate opportunities with novel biologics. The other main group operation is the contract development and manufacturing specialist Samsung BioLogics. ()
But for now, Samsung Bioepis' primary focus remains on biosimilars.
“We are taking a measured, step-by-step approach so that we would gradually develop and complete a full set of capabilities for novel biologic development,” Pak explained. “Our ultimate goal is to leverage our engineering prowess to continue to refine our biologics development platform, so that we can deliver the highest quality biologics, across modalities, and both biosimilars and novel products.”
The company already has one novel biologic in clinical development, SB26, an ulinastatin-Fc fusion protein intended for severe acute pancreatitis being co-developed with Takeda Pharmaceutical Co. Ltd., which codes it TAK-671. Since forging the partnership in the second half of 2018, the two have completed preclinical work and a Phase I trial and are now ready to begin Phase II development.
By Jung Won Shin