Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra™ (infliximab) in major European markets

[DustyKat]

Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra™ (infliximab) in major European markets

-- Major European markets can finally benefit from the availability of Inflectra following the patent expiry of reference product Remicade® (infliximab)
-- Inflectra provides an alternative, potentially more affordable treatment option for people suffering from severe, debilitating diseases such as rheumatoid arthritis and inflammatory bowel disease while maintaining comparable quality, efficacy and safety to the reference product
-- As a result of competition, the large savings expected to be generated with biosimilars can provide an opportunity to improve patient access to life-changing medications.

Full Article:

http://finance.yahoo.com/news/hospira-launches-first-biosimilar-monoclonal-095500870.html

 

[nogutsnoglory]

Fantastic! Hopefully more who need this will be able to access this without financial Barrier.

 

[FrozenGirl]

An interesting note: in Canada Inflectra was approved for most indications of Remicade but not Crohns or UC. Health Canada basically said there was a small difference that could affect the way it works in CD and UC.

 

[droopymonthly]

An interesting note: in Canada Inflectra was approved for most indications of Remicade but not Crohns or UC. Health Canada basically said there was a small difference that could affect the way it works in CD and UC.

Could you please be more specific? Does it mean the cheaper alternative does not work for CD?
BTW, what is the current price for Inflctra in Canada?

 

[kiny]

Could you please be more specific? Does it mean the cheaper alternative does not work for CD?

It doesn't mean that at all. But biosimilars are different from generics, because of how they are manufactured, biosimilars are far more complex . A different cell line during manufacturing can completely change the effectiveness of a medication, this isn't the case with generics.

Part of this argument is justified, biosimilars will need more testing than a generic. Generics are for all intended purposes, the same thing, biosimilars, not completely. Part of it is also just manufacturers trying to prevent cheaper biosimilars to enter the market.

 

[FrozenGirl]

"The indications for psoriatic arthritis and plaque psoriasis were granted on the basis of similarity and the absence of meaningful differences, between Inflectra and the reference product, in product quality, mechanism of action, disease pathophysiology, safety profile, dosage regimen and on clinical experience with the reference product. Scientific rationales submitted by the sponsor were found to be adequate to support extrapolation to the indications and uses pertaining to psoriatic arthritis and plaque psoriasis; however, extrapolation to indications and uses pertaining to Crohn's disease and ulcerative colitis could not be recommended due to differences between Inflectra and the reference product, that could have an impact on the clinical safety and efficacy of these products in these indications. As a result, the benefit/risk assessments for Inflectra in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis were considered to be positive, while the benefit/risk assessment of Inflectra in patients with Crohn's disease or ulcerative colitis could not be completed. Additional information is presented in the Clinical Efficacy and Characterization of the Drug Substance sections."

From: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_inflectra_159493-eng.php

 

[FrozenGirl]

At the submitted price ($650.00 per 100 mg vial), Inflectra is less costly than Remicade ($987.56 per 100 mg vial) for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic plaques, and psoriatic arthritis.

From http://www.pdci.ca/2015/01/05/cdec-final-recommendation-for-inflectra-posted/

Not official on the health Canada website but sounds right.

 

[xeridea]

Yesterday, the FDA approved Inflectra (infliximab biosimilar) for all conditions for which Remicade is already approved.

On a related topic, a Samsung subsidiary is also moving forward with their infliximab biosimilar. Flixabi recently received favorable review by the European advisory committee so it moves a step closer to approval there.