By Christopher Hansung Ko, CEO, Samsung Bioepis
Globally, it’s clear that COVID-19 is greatly affecting all healthcare regulatory decisions, but among U.S. pharmaceutical companies and healthcare authorities, there’s a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. In March, the FDA announced that it would postpone inspections, initially of foreign manufacturing facilities and then eventually domestic facilities, too, and that inspections deemed "mission-critical" would be evaluated on a case-by-case basis. This is an important change because the FDA typically inspects manufacturing facilities to verify that the manufacturers comply with relevant regulations prior to issuing drug approvals.
But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses. Due to mandatory and voluntary social distancing, and a lot of medical resources rightfully being directed to care for those most immediately impacted by COVID-19, the normal operations of clinical trials have been severely limited. Most people consider clinical trials to be a precursor — a necessary step in getting a product approved. But we shouldn’t forget that in a lot of cases, these clinical trials are a last hope for many patients. People who have exhausted all other available treatment options turn to clinical trials as their last chance for survival. It's the same for drug approvals — a lot of good molecules are being developed and are ready to be approved, and any delay could mean a missed opportunity and a sense of lost hope for patients.
As healthcare researchers, developers, and manufacturers, we always talk and think about patients; making sure patients are getting access to drugs, and the general well-being of patients is why we do what we do. COVID-19 has changed the way I think about patients, because after all, every one of us across the globe is equally vulnerable, and most likely will be affected by COVID-19 in some shape or form. And as my patient mindset has changed, I’m also noticing a seismic shift in the way we conduct business: when we check in with our supply partners in Europe, many of our conversations begin and end on a personal, more human level. Person to person. We’re asking how each other is doing, how our families are holding up, and checking in on one another’s health. These bonds have strengthened our employees and partners on a human level and I’m hoping this will only translate into even better working relationships.
If there is any silver lining in the wake of COVID-19, it’s that it is going to change our industry’s attitude toward what it means to be truly global-minded and start thinking about access and equality on a broader level. It’s a hopeful sign to see that pharmaceutical companies are making individual and industry-wide efforts to fight COVID-19, and we at Samsung Bioepis, as a biopharmaceutical company dedicated to development of high-quality biosimilar medicines, are doing our part to combat COVID-19 in our own way. Our employees are staying up late talking to our manufacturing and commercial partners and checking supply logistics to make sure that patients with oncological and immunological conditions continue to be provided with these vital medicines at the right time, without experiencing disruptions. I’m hopeful that we will continue to embrace that inventive spirit in order to create long-term solutions for the patients who need access to high-quality, cost-effective treatments.
In the era of globalization, we often talk about the world as a single global community, especially when discussing the world economy and its impact on everything from the food we eat to the medicines we have access to. But when a disease breaks out in what many consider to be a remote part of the world, that global sentiment dissipates, making way for fear and uncertainty, and we start treating it as “not my problem.” But the coronavirus doesn’t discriminate. COVID-19 is going to change the landscape of the pharmaceutical industry, not only because of the spread of the virus or issues with prevention, diagnosis, and treatment, but also because of the immense impact it will have on the economy as it relates to healthcare. As the U.S. government irons out the details of stimulus packages and people around the world grapple with the financial strain that this virus will undoubtably leave in its wake, we must continue to embrace inventive long-term solutions. The biosimilar sector is one that can help increase access to high-quality medicines, bringing value to patients — expanding access and creating greater cost-effectiveness by driving market competition and innovation. I think especially in the U.S. where the adoption of biosimilars has been much slower than the rest of the world, this pandemic will drive urgency to have quality products at much more affordable prices.
Despite whatever delays COVID-19 causes for FDA approvals, I hope patients choose to not give up the fight, because a change is coming. We need to get through COVID-19 first, but a new dawn is on the horizon in patient-focused care…and we will all surely benefit. You. Me. Us.
About The Author:
Christopher Hansung Ko is the president and CEO of Samsung Bioepis, a biopharmaceutical company dedicated to developing high-quality biosimilar medicines.