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With more than 10 years of experience with biosimilars on the market, not one approved biosimilar has been withdrawn due to efficacy or safety concerns, according to Weise.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The hurdles for biosimilar approval are very high, and several have been rejected or withdrawn due to these stringent qualifications.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a biosimilar fails to show a similar pharmacokinetic profile to its biologic or there are too many uncertainties, it is withdrawn.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.

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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.
 

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 value of biosimilars in oncology.

Weise says that some people in the oncology space may be reluctant to accept biosimilars, as the quest for novel drugs targeting new mechanisms of action is often on the forefront of research efforts. With biosimilars, the field is essentially getting more of the same drug, but Weise says that the reduction in cost that biosimilars could bring may be able to pay for newer and potentially more effective treatments in the future. The sustainability of healthcare systems will depend on the competition and price reductions that biosimilars could introduce to the market, Weise says.

This sentiment is starting to change, though, as physicians and healthcare professionals are beginning to understand the utility and benefits of biosimilars. Additionally, oncologists now have a better understanding of the scientific principles of biosimilar development, for which the guidelines are very stringent.

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

Dr. Weise Discusses the Value 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 challenges with biosimilar acceptance in oncology.

When supportive care biosimilars entered the oncology landscape over 10 years ago, they were met with some skepticism, says Weise. This skepticism is echoed today, as biosimilars for biologics such as trastuzumab (Herceptin) and bevacizumab (Avastin) are awaiting use in the United States. As time has progressed, there has been more understanding as to the regulatory procedure for approving biosimilars, as well as the benefit that they offer.

Not only do biosimilars create competition in the marketplace, but they also offer the opportunity for patients in countries that cannot be offered biologics to receive care, says Weise. She adds that in Eastern European countries that previously had not had access to biologics are now experiencing an increase in the use of biosimilars for the support and treatment of patients with cancer.

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

Martina Weise, MD

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Dr. Weise Discusses the Future of Biosimilars in Oncology

Dr. Weise Discusses the Value of Biosimilars in Oncology

Dr. Weise Discusses Challenges With Biosimilar Acceptance in Oncology