Last week, Samsung Bioepis’ Soliris (eculizumab) biosimilar candidate, SB12, entered a Phase I trial in Berlin, Germany.
The reference product, Alexion Pharmaceuticals’ Soliris, is a humanised monoclonal antibody (mAb) that inhibits the immune system protein, complement component 5, that is associated with damaging inflammatory responses in a number of diseases.
Alexion’s Soliris patents are due to expire in 2020 in Europe and 2027 in the US, and with net sales of $3.14bn (€2.76bn) reported last year, the mAb appears an attractive target for biosimilar developers.
Samsung Bioepis’ research partner, Parexel International GmbH, will evaluate pharmacokinetics, safety, tolerability, immunogenicity, and pharmacodynamic profiles of SB12, in contrast to EU-sourced Soliris, and US-sourced Soliris in 240 healthy subjects. The study is due to begin in November this year, and end in April 2019.
While SB12 is the firm’s most recent development programme to be made public, Samsung Bioepis has “many more early stage candidates not yet in the clinic,” according to VP of Samsung Bioepis’ process team, Brian Hosung Min.
“Right now our pipeline is much deeper than what we’ve made known to the public. If there is a blockbuster antibody out there, chances are we’re developing it,” he added.
Biopharma-Reporter (BPR) sat down with Brian Min (BM) this week to discuss Samsung Bioepis’ beginnings as a joint venture between Samsung BioLogics and Biogen in 2012, to its working culture, growing presence on the biosimilars market, and most recently, a partnership with Takeda Pharmaceutical Company in novel biologics.
BPR: Let’s talk about process innovation. How has Samsung Bioepis advanced its development and manufacturing processes for biosimilars?
BM: Our process of development and manufacturing has evolved. This progress is not ‘random’. It is hard work. We train our people hard so that they are driven. We tell our staff why we’re doing this – to help patients. In addition, our staff is highly educated. Some employees come from Korean biotechs, some from global pharma. We have highly qualified staff doing work with passion, and this is one of the main strengths of the company.
Secondly, I must mention technology. We use all of the state-of-the-art technology available. However, just because these technologies are available, does not mean they are being used in the most efficient way. However, I spend half my time as an executive focused on risk management to ensure a strong quality focus. All our machines are working 24 hours a day, seven days a week, with our scientists working in shift patterns to maximise utilisation.
BPR: How does Samsung Bioepis differentiate itself within the biosimilars development space?
BM: I think we have a different culture. At Samsung Bioepis, people are more focused on doing a good job. I would say that 95% of our time is spent on biosimilar development – focusing on their quality, and increasing efficiency of development and manufacturing processes, so that we can save costs that can be then be transferred to the patients, for their benefit.
As a young company, we are developing our own culture. This is Samsung Bioepis’ culture, not Biogen’s or Samsung BioLogics’ – it is our own, and we continue to develop it.
BPR: Last year, Samsung Bioepis entered a partnership with Takeda aimed at developing novel biologics. How is this partnership progressing?
BM: We are currently developing one product and it is in Phase I clinical trials. It is going fairly well. The deal with Takeda covers the development of multiple products, and so we are still looking at their assets to see what other products we might collaborate on.
We like the model we have with Takeda, which is cost-sharing and risk-sharing. However, we are also looking at other companies and other assets as well. This is ultimately where we’re going to go: currently our biosimilar business is our core business and we will continue to develop and sell biosimilars, but ultimately we want to also go into novel biologics. This partnership with Takeda is our first step.
BPR: The ‘biosimilar’ concept can be difficult for patients to grasp, could more be done to promote biosimilar uptake at a regulatory level?
BM: As a scientist, I don’t want to comment too much on policy, but as far as we can see biosimilar uptake is going well.
Maybe [the biosimilar concept] is hard for patients to grasp, I agree. But these drugs are produced in living cells and it is impossible to have an exact same drug every time. That is why biologics are so highly regulated with very narrow specifications – even with originator drugs, the batch to batch variations exist. They are not exactly the same, and people don’t understand that; they think it is just one product.
It is about educating doctors and patients or other stakeholders that there are variations in all these innovator products as well as biosimilars, and if you understand that, and understand that quality is our first priority and that we are meeting these very narrow specifications to enter the market, then the public should not worry.
I predict that biosimilar companies will take an active role in educating stakeholders. Biosimilars will be more accepted in the future. This industry has huge potential.
Brian Hosung Min is vice president of Samsung Bioepis’ process team, managing all aspects of process development and manufacturing for the firm. Prior to joining Samsung Bioepis, Min was head of antibody engineering at Samsung Advanced Institute of Technology, and worked as a principal scientist for Amgen for more than 10 years.
