EU and US Stakeholders Discuss Experience With Switching

During the GRx+Biosims 2018 conference held in Baltimore, Maryland from September 5-7, 2018, the interchangeability and switching of biosimilars was a crucial topic. Discussing the industry’s experience with biosimilars on a more global level were Marc-Alexander Mahl, MD, executive vice president of the business unit for generic drugs at Fresenius Kabi and president of Medicines for Europe, and Hillel Cohen, PhD, executive director of scientific affairs at Sandoz.

The European biosimilars market differs from that of the United States in multiple ways, though importantly, a main difference is the greater experience Europe has with these particular products. Biosimilars have been available in the European Union (EU) for just over 10 years, providing the member states with greater knowledge and data to draw from when regulating and prescribing such medicines.

Click to view a chart of US and EU biosimilar approvals.

“There are more than 40 biosimilar products approved in the EU, which has already generated worldwide more than 700 million days of patient experience,” explained Mahl. He discussed what he sees as the 3 main benefits of biosimilars: reduction of treatment costs, which allows more patients to have access to treatment; more investments for hospital infrastructure, employees, and healthcare services; and improved care and health outcomes for patients. “In essence, biosimilars are a win, win, win.”

Contrary to experience in the United States thus far, Europe has also seen what Mahl describes as “widespread support for switching biosimilars medicines under the supervision of a healthcare provider.” In fact, regulatory bodies in the EU have spoken out stating that “In our opinion, switching patients from the originator to a biosimilar medicine or vice versa can be considered safe.”

Despite these facts, in the United States, switching a patient from a reference product to a biosimilar remains a hot topic within the industry and is largely contested on the basis of hypothetical concerns about patient safety, said Cohen. A main factor in why the United States’ experience is so different when it comes to switching patients to a biosimilar medication lies in the nomenclature around the practice itself.

In the United States, “interchangeability” is a regulatory term that refers to the substitution of a reference product for a biosimilar at the pharmacy level. In the EU, the term is more clinical in nature and refers to products producing the same clinical result. Industry members still have many questions and concerns around the safety of switching patients to biosimilar medications particularly in the United States, as the FDA has yet to finalize guidance around how drug developers would go about achieving such a designation.

Cohen said that he personally believes switching to be a safe and effective practice. “I was the lead author on a study that retrospectively reviewed over 90 switching studies with varying designs, endpoints, and products that revealed no efficacy or safety concerns,” he noted. This retrospective study evaluated over 14,000 total patients in 14 different disease states and found that, in addition to biosimilars being safe and effective, there was no increase in treatment-related adverse events, no difference in anti-drug antibodies, and no difference in neutralizing antibodies post-switch.

The FDA is expected to finalize the draft guidance document around interchangeability on or before May 2019. Various FDA officials have noted that they intend to keep to this deadline, as industry members continue to reiterate the importance of this highly anticipated document for the potential future of the biosimilar market as a whole.