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Biosimilar Confidence Factor Pops on New Data

We are going to hear a lot more about biosimilars in coming days. The leader board now shows that 44 biosimilars have been approved to date…. even including a handful of interchangeable products. After initial slow uptake, biosimilar demand is really starting to percolate as these products elbow their ways onto payor formularies.

One of the biggest drags on biosimilar adoption has been confidence. 

Patients… and even providers…. have been reticent to try a biosimilar….. especially when the reference product could be obtained for the same out-of-pocket cost through a payor.   The trend towards increasing coinsurance (generally based on wholesale price) is a factor that is contributing towards patients and providers looking kindlier at biosimilars.  

But, is out-of-pocket cost enough to move the needle…. pun intended? NO

What is really needed is proof of concept. For many new products confidence can be determined in quick order…. even minutes. Medicines, however, need long timelines to prove their mettle…. even years. Well, the years are passing and, finally, biostatisticians are now cobbling data together to show long term biosimilar efficacy. 

The article below is one of many that we should be seeing as post marketing outcomes data for biosimilars are published. The article below details the efficacy of several Oncology biosimilars…. arguably the most challenging category in which to shine. Strong data will go a long way to bolster that confidence factor we mentioned above.


Oncological Biosimilars Shown to Be as Safe as Their Reference Products

Study finds patients with cancer feel reassured that biosimilars provide a safe, adequate, and cost-effective alternative to the pricier reference drug.

Biosimilars are commonly used in numerous clinical fields, including oncology. These drugs are different from the generic form of chemical products because it is impossible to develop molecules identical to their reference products due to natural variation and their heterogenic product process. Biosimilars are comparable to the reference product regarding structure, biological activity, efficacy, safety, and immunogenicity; however, there is some skepticism surrounding the safety and efficacy of these products among physicians and patients.

In a study published in Cancers, researchers analyzed post-marketing pharmacovigilance data of biosimilar monoclonal antibodies used in oncology compared with their respective reference products. The study authors evaluated the distribution of medicine-reaction pairs related to biosimilars of 3 antitumor biological products—bevacizumab, rituximab, and trastuzumab—as well as their respective corresponding biosimilar drugs—Avastin, MabThera, and Herceptin. ….. article continues

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FDA Approves Biosim to Actemra – Tyenne

……. catching up on FDA approvals The FDA recently approved another tocilizumab biosimilar, Tyenne (tocilizumab-aazg) from Fresenius Kabi, indicated for Rheumatoid arthritis, Giant cell arteritis,

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