Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday.
Leah Christl, associate director for therapeutic biologics at the US Food and Drug Administration (FDA), on Monday presented on a recently released FDA draft guidance for industry on interchangeability, outlining the studies necessary to win the designation, including the use of switching studies. She previously said interchangeables could be coming in the next two years.
Boehringer Ingelheim recently became part of a growing group of companies seeking to market interchangeable biosimilars and announced that the first patient has been enrolled in an interchangeability study to bring an interchangeable Humira (adalimumab) biosimilar to market in the US. More than a handful of companies are targeting Humira and other blockbuster biologics in an effort to bring competition to lower costs. To date, six biosimilars have been approved in the US, though none are interchangeable biosimilars.
In the EU, biosimilars have seen more approvals than in the US (though some follow-on products are designated as biosimilars in the EU but not the US) and some markets are seeing higher uptake.
Andrea Laslop, head of the scientific office in the Austrian Medicines and Medical Devices Agency, at RAPS' Regulatory Convergence on Monday presented on the biosimilar approvals and sponsors in the EU so far.
Enrica Alteri, head of human medicines research and development support division at the European Medicines Agency (EMA), also discussed what can limit the uptake of biosimilars.
Is an Interchangeable Better?
Continuing this theme on interchangeability in the US, Hillel Cohen, executive director of scientific affairs at Novartis' Sandoz, offered perspective on the potential for misinformation to spread, particularly on whether an interchangeable biosimilar might be considered better or more effective than a biosimilar.
“An interchangeable is not a higher quality product. It's an additional data requirement,” he said at the Biosimilars Council's conference in Washington on Wednesday.
He also discussed the Biosimilars Council's comments on the FDA draft guidance, areas where revisions are being sought, state substitution laws and the terminology.
FDA Guidance on Biosimilars
EMA on Biosimilars