We all want cheaper drugs whether they are the standard molecular drugs we have known for years and if one is diagnosed with cancer of course anyone would want the latest and best treatments, that kind of goes unsaid.image

Bio similar drugs are much more complex to create and it takes a lot more time as if each drug delivered the same punch with immunotherapies for example we would have it made but all drugs are not for the masses and of course this is where personalized medicine and genomics jump in.  Unlike molecular drugs, the biosimilars are just that, similar as they do not have access to the proteins, which the company who created the drug can keep under locks forever. 

Biosimilar Drugs – Approval and Process Appears Cloudy On the Biologic License Applications With HealthCare Reform Law and The New “Pathway”

Biotech companies thus so have a hard time getting financing as well as those who invest are in it for the long run and some flat out don’t make it.  With that being said, can you see why our lawmakers are having such a tough time with this, as it is complex to create laws that will be fair and equitable all the way around.  Some major pharma companies are already in the biosimilar market such as Merck and Pfizer each with their announcements over the last couple of years.  The point here is well made in the fact that by the time it takes to simulate the protein in the biotech drug, where does the line draw on how much time and money a company will invest and then again we have the end result of whether or not it will be cheaper after money and time is calculated.  BD

It has been a long time coming, but stakeholders in the US are now seriously debating a route to market for cheaper copies of biopharmaceutical drugs. The European Agency for the Evaluation of Medicinal Products (EMEA) has led the way on this issue by publishing clear guidelines on what companies must do to get their versions of drugs such as erythropoietin (EPO), an advanced treatment for anaemia, and similar products approved.

Biotech drugs such as Herceptin and Avastin — monoclonal antibodies approved for treating breast and colorectal cancer — are valued because they have an innovative mode of action. But this value is reflected in the price tag: a biopharmaceutical medicine can cost up to 30 times more than a conventional small molecule drug. Put simply, if everyone who could benefit from a recombinant protein or monoclonal actually received them, it would sink healthcare budgets everywhere. So, of course, there is pressure to produce cheaper copies as patents begin to expire on drugs such as EPO, the interferons (used to treat multiple sclerosis and hepatitis B and C), growth hormone and the clot buster tissue plasminogen activator.

A pharmaceutical manufacturer hoping to enter the biosimilars market would actually face a double challenge. First, it is harder to make biotech drugs than small molecules because of their increased complexity. "There is a quantum leap between making chemicals and making proteins," warns Fox. Additionally, making a biosimilar involves making a copy of someone else's protein without their experience and know-how (which the innovator can keep secret indefinitely).

Hence, the biosimilar manufacturer will have to come up with plenty of data to show the regulatory authorities that their product does not have a glycosylation profile that is going to compromise efficacy or, more seriously, patient safety. Companies such as Teva (which markets biosimilars in developing countries), Sandoz and BioPartners are meeting these challenges. Sandoz' Omnitrop, a growth hormone, was the first biosimilar to be approved in Europe (after extended legal wrangles in the European court). But the drug was not without teething troubles — the presence of host cell protein (often an issue in biotech manufacturing) led to antibody generation among some clinical trial participants. Sandoz fixed the problem, but it illustrates the inherent unpredictability of biosimilar production.

Valtropin, another growth hormone, from BioPartners, was the second product to be approved by EMEA and biosimilar versions of EPO and G-CSF may soon follow. The costs of biosimilars may turn out to be higher, compared with the original drug, than conventional generics because of manufacturing and regulatory issues. And, of course, biosimilars are versions of relatively old drugs. Biotech companies have hardly been standing still while the drugs now up for copying progressed through their patent lives. Their latest products, and those in the pipeline, are likely to be safer and more effective than the earlier versions — such as Amgen's darbepoetin alfa (Aranesp, an advanced treatment for anaemia, which could be used instead of EPO). Will the patient offered a biosimilar be getting an inferior medicine? That's a debate still to come.



  1. This is a good article that discusses the hype surrounding the proposed savings of biosimilars and what actually might become reality.

    Although the development costs are likely to be extremely high in order to demonstrate similarity, what you also must consider is the protection of innovator's drug manufacturing processes, which the fda must review to approve new biosimilars. This is a major area of concern if biosimilars are ever to hit the market.



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