Tony Hagen is senior managing editor for The Center for Biosimilars®.
Christopher Hansung Ko, PhD, president and CEO of biosimilars company Samsung Bioepis, discusses innovations and precautions the pandemic has brought to the field of biosimilars.
With the pandemic raging, things are done differently in the biosimilars sphere these days, Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in an interview at the Financial Times Global Pharmaceutical and Biotechnology Conference 2020.
For one, regulators seem motivated to move applications along swiftly, he said. “Regulators are acting much faster than they ever have. I’ve never seen clinical trials being approved this quickly. And their willingness to engage and look at the interim results…has been welcoming sight. I hope that regulators will continue this type of approach post-pandemic. Then we’ll see a much greater number of products being approved in a short period of time.”
Watertight and "Redundant"
On the other hand, the pressure is on to make supply chains watertight. This has meant building in redundant systems to ensure that if there’s a breakdown in process or supply flow, the goods can get to market, he said.
“The pandemic taught us that we need to be better prepared as a company and as an industry. Redundancies have been built into vendor selection, raw material production, and shipping methods.
“Prior to the pandemic, it was taken for granted that this much duplication was unnecessary, but we realized that we needed to become experts at those details and be vigilant about it,” Ko said. It was also necessary to become more involved with suppliers to understand their operations and COVID-19 precautions “to make sure that they had enough staffing and that people were being trained as backup.”
This also goes for ensuring the success of clinical trials, he said. Those who sponsor and run clinical trials want to be sure that sufficient quantities of experimental drugs are going to be available.
“It’s still very difficult with current restrictions and with the second wave that’s hitting Europe and the United States,” he said. “These are sort of the last hopes for the sick patients—to be on clinical trials to get affordable care. We have to constantly communicate to investigators, nurses, and patients to give them the assurance that the investigational product will be delivered so they can plan ahead.”
Samsung Bioepis is an Incheon, Republic of Korea–based joint venture between Samsung Biologics and Biogen. Predominantly a biosimilars company, Samsung Bioepis has 5 drug products launched in Europe and 2 in the United States.
Biosimilars represent a means of expanding access to medicines during coronavirus disease 2019 (COVID-19) because as they are introduced, they enable health care institutions to save money and use these savings to expand other types of care, Ko said.
“All countries globally are concerned about the rising health care cost. There’s a limited amount of money they can spend on health care, but innovations have to happen, and there’s built-up pressure that can no longer accommodate new innovation, which makes biosimilars the pressure valve,” he said.
And the savings can be enormous, Ko said. This is partly because modern biologic manufacturing processes have evolved and even current systems of producing biosimilars may be far more efficient than ones originally used for creating the reference drugs.
“We’re using state-of-the-art, cutting-edge technology with process innovations. We’re able to deliver our products at much lower costs. In some territories, we’ve seen biosimilar prices discounted 80% to the originator.” The savings potential is significant, he said.
A More Concerning Wave
Despite all the precautions to ensure production continuity during the pandemic, the resurgence of this virus across the globe is reason for concern, Ko said. “The number of patients diagnosed is far greater than in the first wave, earlier in 2020. I’m concerned about people’s movement and people’s inability to go to the doctor’s office and get new prescriptions filled and receive a diagnosis,” he said.
Also, pandemic limitations on movement are reshaping product development, Ko said. “Traditionally, all oncology products were infused, so this required infusion chairs at clinics, and those are becoming a much more costly option for health care systems. Now, they’re trying to use subcutaneous formulations that patients can administer at home. We will continue to see the migration from an infusion setting to a self-care type of subcutaneous, auto-injectable space or some other format that allows a patient to administer outside the clinic,” he said.