- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Hans-Christian Kolberg, MD: Real-World Evidence and Biosimilar Trastuzumab
Hans-Christian Kolberg, MD, head of the department of obstetrics and gynecology, breast cancer center, and gynecologic cancer center at Marienhospital Bottrop, Germany, discusses the role of real-world evidence for biosimilar trastuzumab.
Transcript
Real-world data are something that are needed, and actually that is one of the huge problems we have. For companies selling biosimilars, real-world data are after-sales service. It’s very difficult to get funding for that.
We are at the moment planning a study, a real-world study on cardiac safety. We’re trying to predict cardiac safety with early endpoints by drawing blood after 2 cycles of the biosimilar—of antibody—trying to measure in the blood biomarkers that may predict cardiac failure in patients.
This is a classical real-world study, and this is very important because cardiac safety, the cardiac signals in trastuzumab trials, have been decreasing over the years, not because trastuzumab is less cardiotoxic, but because people are more aware of cardiotoxicity, and of course the inclusion/exclusion criteria have been developed and are more strict. So we may ask ourselves, is this really real-world that we’re seeing?
This is why we believe doing a real-world study—and actually, we found a sponsor for that study—it’s very important to include all patients who are, in the real world, candidates for trastuzumab in a safety study, and not only from a clinical registration trial. Of course, inclusion/exclusion criteria are designed so you’re safe for ethical reasons.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
