Cory Wohlbach is responsible for steering Teva’s new biosimilar products through the regulatory approval process. He explains what biosimilars are, how they have the potential to reduce costs for patients and how patient safety is always a top priority.
Most people have no idea what biopharmaceuticals are. In a nutshell, they are complex medicines that are made from living cells or organisms. They’re usually made using cutting-edge biotechnological methods and have the potential to provide precise and targeted treatments for patients. This is a fascinating area of science that is advancing more treatment options for patients, some of whom suffer from untreated conditions.
There are two regulatory pathways for biopharmaceuticals: biologics and biosimilars. A biologic is the original version of a biopharmaceutical treatment, sometimes called an innovator biologic. Biosimilars – the area that I spend most of my time working in – are medicines that are highly similar to the original innovator biologic. In many ways, focusing on biosimilars is a natural progression for Teva given our leadership in producing generic medicines. We’re using this experience, together with our next generation bio-technology and knowledge of complex molecules, to build our portfolio of biosimilar medicines.
My job is to help Teva get its biosimilar medicines approved and out to patients. Regulatory affairs collaborates with every area from research and development to manufacturing, marketing and sales, and legal. Like all medicines, biosimilars need to be approved by government regulators, such as the Food and Drug Administration (FDA) in the U.S. and the European Medicines Association (EMA).
I was the first in my family to go to college. When I was a boy, I loved science and I wanted a job that helped people. When I started working in the pharmaceutical sector in the lab doing quality control, I had no idea regulatory affairs was such an important role. Now I get to do exactly what I aspired to – work in science and help people. This is different to a lot of my family. I come from a long line of farmers in Pennsylvania and I can trace my family back all the way to the first German immigrants to America in 1705.
Helping shape things and influencing change is probably the most rewarding part of my job. I spend most of my time steering Teva’s biosimilar drugs through the regulatory pathway. I work with government regulators and trade associations to share my expertise, comment on guidance and build understanding about biosimilars and the benefits they can offer patients. I’m also working to influence regulators to help create new policies and pathways that streamline the approval process, and reduce the regulatory cost and overall cost of developing biosimilars.
Patient safety is always a top priority. We have to show that our biosimilar product is highly similar to the original biological product, works in the same way and has no clinically meaningful differences in safety or efficacy. To do this you obviously need scientific knowledge but you also need excellent analytical and interpretation skills, and a strong eye for detail. You need to be tenacious and ask the right questions but also trust your own experts. It’s an odd combination of being totally in command of detail while also being able to see the bigger picture.
Developing a drug takes years and sometimes decades. When it comes to approval, you can’t just take the gigabytes of research and data that has been gathered, hand it over to the regulators and say, ‘You figure it out.’ The skill is in analyzing and interpreting evidence generated across the company and presenting it intelligently and convincingly.
Biosimilars have the potential to reduce healthcare costs for patients. Take the U.S. as an example – roughly a quarter of the national prescription spending is on biologic medicines but only 2% of patients use these medicines 01 . Biosimilars are potentially less expensive than original biologics but have the same effectiveness. It is estimated that the use of biosimilars could save the U.S. health system a minimum of $54 billion over 10 years 02.
Biosimilars are still relatively new. The first biosimilar medicine in Europe was approved in 2006. The first approval in the U.S. didn‘t come until 2015. Thankfully, we’re seeing signs of a more cohesive global approach to biosimilars regulation. However, more needs to be done. It takes concerted efforts not just between regulators but across the industry, and I’m involved in efforts to raise awareness of the benefits of biosimilars.
One of the best parts of my job is working with world-class scientists to develop medicines. Teva has multinational teams spread across the globe, from the U.S. to Germany, Israel to Australia. Collectively, we are working on treatments related to oncology, the central nervous system and respiratory conditions. At the moment there are approximately 20 biologic and biosimilar programs in various phases of development, from discovery through to clinical and regulatory stages. We have a number of exciting opportunities on the horizon, and I’m fortunate to be able to work with such a great team and, ultimately, help patients.
‘Breaking Through on Biosimilars’ report by The Biosimilars Council (May 2018).
Mulcahy et al., 2018. ‘Biosimilar Cost Savings in the United States’. Rand Health Q.