gene silencing

In this episode, the editorial team discusses the FDA approval of Cyltezo as the first interchangeable biosimilar for AbbVie’s Humira. The approval lends to the growing Humira biosimilars market, which will take off in 2023 with Boehringer Ingelheim’s Cyltezo and biosimilars from Amgen, Merck and Alvotech. AbbVie has been facing a lot of heat over accusations of price gouging and patent abuses to block Humira biosimilars from entering the market. The team had an interesting discussion about public perceptions of generics and biosimilars versus their originals/reference products.

Ayesha also talked about a new gene silencing treatment for porphyria called Givlaari that received recommendation from England’s NICE after having been initially rejected by the health watchdog last year. Additionally, long-term results from a late-stage trial for Givlaari were recently released, which showed that the treatment provides sustained benefit and has a good safety profile. However, the team discussed the high cost of the treatment, which is a concern for patients in countries that don’t have some form of socialized healthcare.

Read the full articles here: 

Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar 

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data 

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Naim Alkhouri and Jörn Schattenberg join Roger and Donna to review the closing session of NASH-TAG 2021, a potpourri of basic science and review of promising drugs earlier in development.

The Saturday afternoon closing session of NASH-TAG 2021 spends half its time discussing basic science issues and the other half with BioPharma company drug developers discussing their promising drugs in development. Last year, this session yielded some real fireworks! On Sunday, join SurfingNASH to sort out how what the data means, how the pieces fit together and what questions will require more exploration. If you send us any questions emerging from Session #4 or the podcast, we will review them in our NASH-TAG wrap-up episode next week.