Oncobiologics' Humira biosimilar candidate meets primary study endpoints

[DustyKat]

Oncobiologics has announced that ONS-3010, its Humira biosimilar product candidate, has met primary pharmacokinetic endpoints in a clinical study.

ONS-3010 is being developed as a biosimilar product to Humira (adalimumab, AbbVie), an anti-tumor necrosis factor-alpha (anti-TNF-a) monoclonal antibody currently approved in the U.S. and other countries for the treatment of multiple inflammatory diseases, including plaque psoriasis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Although ONS-3010 has a different composition than adalimumab, it contains the same amino acid sequence, pharmaceutical dosage form and strength, according to a company press release.

The three-arm, single-dose pharmacokinetic (PK) study in the Netherlands compared ONS-3010 to both U.S.- and E.U.-sourced adalimumab reference products, and the two reference products to each other in healthy volunteers, according to the release. Bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80% to 125% was met in all PK endpoints, the release stated.

Maximum serum concentration, area under the time-concentration curve from first time point extrapolated to infinity, and area under the time-concentration curve from first to last time point measured were the study’s primary endpoints.

The three arms of the study displayed similar safety and immunogenicity, according to the release.

Positive results between ONS-3010 and the reference products on TNF-a blockade and the induction of specific inflammatory responses were also observed in an exploratory ex vivo pharmacodynamic study, according to the release.

http://www.healio.com/dermatology/psoriasis/news/online/{dd9e0089-f427-4bcb-b748-ae360baf1afe}/oncobiologics-humira-biosimilar-candidate-meets-primary-study-endpoints

 

[Layla]

So do you think Humira will come down in price or will this new one charge the same ridiculous price?

 

[DustyKat]

Until the patent on Humira expires (US Dec 2016, Europe April 2018) I can’t imagine the price will change.

I don’t know about the new drug but I expect it would enter the market at similar pricing to Humira if it is comparable in dose and administration??

 

[Layla]

Yes I expect you're right

I think my GI mentioned that it was quite difficult to make and that would be another reason to keep the prices up I guess, pity!

I just had my loading shots last Friday, NZ$7200, wow! Thankfully we have public health so it only cost me $5 but that means other people will go without somewhere along the line....

 

[DustyKat]

As much as we hate the cost of these meds it can’t be denied that the R&D that goes into producing a viable product is pretty damned hefty.

Too right, thank goodness for universal health! I have a feeling that it is the US that is the one paying the price in most instances. Whilst on the one hand they are able to access the drugs far quicker than elsewhere the trade off is the cost to the consumer/insurance company.

 

[Clash]

I bet the price stays up for sometime. I remember reading an article awhile back about the FDA having stringent guidelines for biosimilars to meet to pass regulations.

Our insurance aprroval just came back. Our out of pocket expense is 60.00 for one month supply or 120.00 for 3 month supply but with our My Humira card it's just 5.00.