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Existing FDA-Approved Biosimilars


Jonathan Kay, MD, provides an overview of the existing FDA-approved biosimilars for adalimumab.

Ryan Haumschild, PharmD, MS, MBA: As we jump into understanding the indications and treatments, I’ll turn to Dr [Jonathan] Kay. Could you provide an overview of the existing FDA-approved biosimilars for adalimumab [Humira] and the differences between the low and high doses that we’ve heard so much about?

Jonathan Kay, MD: As of June 19, 2023, [there are] 9 FDA-approved adalimumab biosimilars. Some of these are low concentrations. Some of them are high concentration. There’s 1 company which has both a low concentration and a high concentration in a citrate-free buffer. Some of the adalimumab biosimilars are in a citrate-containing buffer. Others are in a citrate-free buffer. Most of the auto-injectors use a 29-gauge needle. One of them uses a 29-gauge needle or a 27-gauge needle. The 27-gauge needle is in the auto-injector and the 29-gauge needle is in the prefilled syringe. All of the adalimumab biosimilars that are being marketed, for the most part, have patient assistance programs. The patient assistance programs are comparable to that which is offered by the manufacturer of referenced adalimumab. So there’s a wide array of adalimumab biosimilars that are coming on the market. One of them, adalimumab-atto has been marketed since January 31 and has a head start. But as of July 1, there are going to be 7 more adalimumab biosimilars that come to market. And then in September, we’re going to see the last of the 9 adalimumab biosimilars coming to market in the United States. Why 2023? There was patent litigation by AbbVie with each of the biosimilar manufacturers, which stalled the availability of biosimilar adalimumab. Biosimilar adalimumab was available in the European Union and elsewhere in October 2018. But in the United States, each of the biosimilar manufacturers reached an agreement with AbbVie whereby they would pay a royalty to AbbVie for intellectual property rights and would be allowed to release their biosimilar to market in 2023 with prespecified dates.

Ryan Haumschild, PharmD, MS, MBA: That’s a great overview and a great background as to maybe why we’re seeing it here, and maybe why we can also look to European data if we’re having any hesitation in terms of uptake here in the US.

Transcript edited for clarity.

This activity is supported by an educational grant from Boehringer Ingelheim.

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