What Are Biosimilars?
Biosimilars are biomedical drug products, or pharmaceutical drugs, that are manufactured from biological sources. Meaning these drugs are typically developed through biotechnology in living cells or tissues, or from items that can be broken down in the body such as sugars, proteins, nucleic acids, plant cells, animal cells, etc. Biosimilar drugs that are made of these or a combination of these ingredients are an almost identical copy of an original product that is made by a different company. Once the original product's patent expires, biosimilar drugs are manufactured and marketed for usage. These products also go through tests and trails to ensure FDA biosimilar safety.
Biologics Price Competition and Innovation Act of 2009
Formerly passed under the Patient Protection and Affordable Care Act, the Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was originally sponsored and introduced by Senator Edward Kennedy and signed into law under President Barack Obama's administration in 2010. This act created space for biological products that demonstrated high similarities, aka biosimilar products, to receive approval from the Food and Drug Administration to be manufactured and marketed as an FDA biosimilar.
Examples Of Biosimilar Drugs
Some examples of biosimilars on the market are Infliximab a drug that is used to treat autoimmune diseases, such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, and more. The original manufacturer for this type of drug is Remicade. Adalimumab is yet another example of a biosimilar that treats various types of arthritis, ulcerative colitis, and psoriasis. from its TNF-inhibiting, anti-inflammatory properties. The original of this product is known to many as Humira. Costs in 2017 calculate Humira at $4,370 per month with its biosimilar, which was created in India, at $200 per month.
Biosimilars Vs. Generic Drugs
Although biosimilar and generic drugs have similarities with offering consumers a more cost affordable option than purchasing the original drug, there are some discrete differences and similarities with both. To start, both have to be approved via the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) via clinical trials and tests to be acceptable for usage. Generic drugs, though, must have the same active ingredients as the original name brand drug.
The manufacturer of the generic drug must also demonstrate the drug is biologically equivalent in properties and function. Biosimilar drugs on the other hand only has to demonstrate that it is highly similar to the manufactured drug, and does not have to be an exact match, except with minor difference in inactive ingredients. Manufacturers of biosimilars must also show they are no differences with safety and effectiveness from the original product during clinical trials.
Why Biosimilar Drugs Are So Important
Biosimilar drugs are important because they provide consumers with cost-effective options to purchase drugs that may be important to their health and well being. Biologics, or what is known as the original drug, are more complex and costly to develop and produce, which can leave people serious ailments at risk of not being able afford the products. Although regulations have allowed for biosimilar product choices to be more prevalent in Europe and Canada, US market continues to work with the FDA to set guidelines to make it easier for more firms to enter the market.
In the US, legal requirements for proving FDA biosimilar products plus the cost of manufacturing can cause expenses to rise to the millions. One such guideline to help regulate costs for biosimilars is the patent cliff, where pricing of FDA biosimilar products will drop once the original product patent expires.