Dr. Weise Discusses the Future of Biosimilars in Oncology

Martina Weise, MD, head of Division Licensing 2, and German CHMP member of the Federal Institute for Drugs and Medical Devices, discusses the future of biosimilars in oncology.

With more than 10 years of experience with biosimilars on the market, not one approved biosimilar has been withdrawn due to efficacy or safety concerns, according to Weise. She says that although there will always be believers and non-believers, physicians have become increasingly comfortable with the idea of using biosimilars in oncology.

The hurdles for biosimilar approval are very high, and several have been rejected or withdrawn due to these stringent qualifications. If a biosimilar fails to show a similar pharmacokinetic profile to its biologic or there are too many uncertainties, it is withdrawn. Not every biosimilar makes it, Weise emphasizes. More trust needs to be built into the regulatory system, she adds.