It’s a new trend that’s gaining momentum in the arena of medication. There are a host of copycat medicines that are coming our way, which are set to revolutionize medicine costs, offering more customized treatment. Chemically synthesized drugs like cholesterol-lowering Lipitor, the one-time pharmaceutical sales leader, gained a host of replicas churned out by generic drug companies once patent protection expired. But in the near future, that kind of drug will no longer be the hottest object of imitation. Now the blockbusters to copy are biologics like Remicade.
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March 2015 marked a turning point in the America pharmaceutical industry when the FDA sounded the bugle for the first biosimilar drug. While this has sparked off a heated debate in the pharma world, industry figures suggest that biosimilar drugs have a booming market lying ahead.
In 2011 alone, highly regulated markets had biosimilars owning a $700 million share, says an IMS Health report. The report predicts that in the coming year, the sales of biosimilar drugs is set to exceed $4 billion. And by 2020, sales of biosimilars – especially major selling ones – is projected to cross the $11 billion mark, what with several patents and market exclusivities set to expire.
How are biologic drugs made?
Biologic drugs are much more complicated to produce than chemical drugs. They are made from genetically identical copies of a master cell that has is changed through a technique called gene splicing. In gene splicing, materials from two or more genes are inserted into another gene to produce a unique protein or substance that can help the body combat an illness. This unique master cell can create established cell lines that can produce proteins and antibodies en masse, combating diseases within the body.
In order to produce these proteins, the master cell is placed in a culture where it multiplies. It is then transferred to large vats where the growing cells are processed and monitored at exacting conditions until the desired quantity of protein has been produced. This process results in the production of the specific protein needed for the biologic medication. The protein is then extracted from the cellular culture, purified, and stabilized. Every biological drug manufacturer has a cell bank to produce its own unique “cell line” derived from the master cell, using its own exclusive manufacturing process to produce its brand name biologic.
Copying a biologic is technically challenging
Biologic drugs are produced in a living cell and not in a chemical plant like regular chemical drugs. This makes each biologic drug unique in its own way, with its own mix of complex, variable biomolecules. The best copies can be only highly similar to the original, but rarely the same as every manufacturer has his unique process of creating it. The aim in developing a “biosimilar” is to reproduce the overall structural, functional, and clinical characteristics of an original product so that it has the same safety and efficacy. Even minor manufacturing changes yield different products.
Compared to small-molecule generics game, biosimilars require ample investment of time and money for a payoff that is still uncertain. It may take about eight years and $250 million to produce a biosimilar drug. Figures may vary depending on the size and number of clinical trials needed. Expenses related to cell line characterization, pharmaceutical sciences, analytical comparability and the volume of analytics is nothing less than four to five times greater than that spent on chemistry, manufacturing and control packages for innovative products.
This business is definitely not carved for the faint of heart, what with regulatory bodies training a hawk’s eye to ensure that compounds are close enough to take advantage of an abbreviated approval pathway.
Why would physicians refer a biologic drug?
Biologics have changed the way many very serious diseases are treated. In each disease category for which biologics are used, the goal may be different. Some may look at destroying or halting the production of a cancer cell, some at replacing a missing protein or hormone, while some target and suppress the production of proteins that cause damage to a tissue.
Most often than not, when treating autoimmune diseases, physicians may start the therapy with less aggressive treatment and then progress, as needed and appropriate, to higher risk therapies to achieve better control of the damaging effect of the disease.
Now, treatment with biologics can stop or slow the progression of a disease. In such scenarios they may be used early-on in the course of disease progression to prevent irreversible damage to joints or organs. The decision to take a biologic or a traditional chemical drug differs from physician to physician and patient to patient.
Because biologics are highly specific therapies, they tend to work best for patients with the disease profile that the drug targets. In some cases, physicians may prescribe a “step therapy” whereby patients are started on a chemical drug and then moved to a biologic drug when the chemical drug is either not tolerated or no longer effective.
All in all, biosimilar drugs are set to rule the stage in the coming years. While Remicade is the favourite target of the copy cats now, it won’t be long before the market is flooded with biosimilars that may revolutionize, customize and reduce healthcare costs dramatically.
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