There are three stages to the product life cycle that can be applied to many things. The stages are introduction, growth, maturity, and decline. Many things go by these stages; toys, styles, diets, and even medications. During the ‘Maturity’ stage is when things are going great. The product has probably reached its peak and another thing begins to happen. Imitations begin to make way and competition appears. For example, generic forms of medications are coming out frequently. On a related note, so are biosimilar drugs.
You can think of biosimilar drugs just like an imitator or generic drug but the real difference comes into play on a molecular level. Two cells developed separately, cannot be exactly the same. Also, without knowing the exact methods and manufacturing used in the original drug, the biosimilar will be just so different that it’s not the same product. As defined by the European Medicines Agency (EMEA) the term biosimilar actually means the second drug is similar but not identical enough to be considered a copy of the original drug.
The active ingredients in biosimilars are huge molecules with complicated structures that are difficult to replicate exactly. Even those created by the original manufacturer can contain minute differences from others. In short, making a generic drug is a simpler process and will result in a product much the same as the original. Some biosimilars, for these differences, may not exactly match the precautions and uses of the original.
The term biosimilar comes from biologics or biomedical drugs. These are drugs produced from living things like cells or antibodies with the purpose of therapeutic effects. A biomedical drug can be protected from copyright with a patent. With anything else that’s patented, imitators change just enough to not violate the original product’s patent. There is a law in effect that says the producer company of the original drug has the right to exclusive production for 12 years, meaning after 12 years biosimilars will start to pop up and create competition in the way of a similar drug. The previous time for the patent was 20 years but a new proposal in 2009.
With the amount medicated drugs can cost, biosimilars are just as popular as generic brands when it comes to saving money. With biosimilars in general at 20-30% lower price than an original drug they’re becoming more popular among the drug market.
Biosimilars are becoming more and more popular; it’s up to the FDA now to determine exactly how different a drug must be to be a biosimilar and not a copy. They also must determine how much extra testing must be done on biosimilars before they’re able to be put on the market, as they are considered ‘similar’ to the original drugs. Drugs of this sort are becoming more common and you can expect to see more concerning them in the future.
