Biosimilar Bytes for This Week

Although big biosimilar news has been lacking in the last couple of weeks, there are several newsbytes that are of interest to industry followers. Here are a few of the more notable biosimilar news items.  

The COVID pandemic hadn’t had significant implications for biosimilar developers, but news of a deferred FDA approval decision for an investigational bevacizumab biosimilar may have broken the streak. The approval of product MYL-1402O from partners Biocon and Mylan (now Viatris) will be delayed because the FDA has not yet inspected Biocon’s manufacturing facility. According to a regulatory filing, Biocon does not yet have a schedule as to when the inspection will occur. We originally projected an FDA decision in the first quarter of 2021, based on a 351(k) application in March 2020. Biocon and Mylan are vying to become the third Avastin® biosimilar to be approved and launched in the US.  

Coherus has discontinued its aflibercept biosimilar development program (CHS-2020) as it diverts finances to developing a new PD-1 inhibitor with Junshi Biosciences. This leaves Coherus with three biosimilars in their pipeline: adalimumab, ranibizumab, and bevacizumab. The latter two are licensed from other biotech developers; CHS-1420 is a homegrown biosimilar version of Humira®.

Earlier this month, we highlighted Outlook Therapeutics, a company that is seeking to challenge the branded biologic and biosimilar ophthalmology market with a manufactured intravitreous injection of bevacizumab. Outlook recently announced the completion of recruitment of its final safety study, an open-label investigation. The results should be announced in the second quarter of this year, according to the manufacturer. Combined with the upcoming release of its phase 3 trial results, Outlook confirmed that it is on target to submit a 351(a) application to the FDA in the fourth quarter of 2021.Celltrion has begun its phase 3 trial of its aflibercept biosimilar CT-P42. This trial will be recruited through 13 countries and should serve as the pivotal trial for its regulatory applications. In addition, the company received approval in Canada to market its subcutaneous version of etanercept. Considering it was approved in Europe in 2019, the agent Remsima SC seems to be poised for a 351(a) FDA filing perhaps as early as this year. It cannot be considered a biosimilar, because a subcutaneous version of the reference product Remicade® does not exist.    

(Note: This article was corrected and updated February 18, 2021).

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