Generic Copaxone May Be Available Soon, but What's the Difference?

Mylan, a global pharmaceutical company, announced that it’s ANDA (abbreviated new drug application) for a generic form of Copaxone was accepted for filing by the U.S. Food and Drug Administration (FDA) late August. Mylan’s Glatiramer Acetate Injection will be released as a three times weekly injection of 40mg/mL, similar to Teva’s newest version of three times weekly Copaxone. Currently Copaxone is Teva’s most profitable medication, making up 50% of their total profits. Teva filed legal action in an attempt to block the availability of a generic version of Copaxone, but was ultimately unsuccessful. This is the first disease modifying agent to have a generic version available, which often raises the question: what is the difference between generic medications and brand name medications?

When a pharmaceutical company develops a new drug they have to do extensive clinical research, and ultimately gain the approval of the FDA, before they can manufacture and market their drug. The process of developing a drug, running clinical trials, and getting FDA approval is expensive and complicated. In fact, the entire process from start to finish takes an average of 12 years, and many drugs fail to ever get FDA approval. If a drug is approved by the FDA, the pharmaceutical company that manufactured it holds a patent on the chemical composition of the drug. This means that no other company can replicate it, and it guarantees that all of the profits go to the original manufacturer. Once the patent on the brand name drug is expired then the market opens up and other pharmaceutical companies can manufacture the same drug and sell it as a generic version. Generics are often significantly less expensive, mainly because they do not have to spend the enormous amount of time and money required to develop and test the drug.

Once a company has produced a generic medication they file an ANDA application with the FDA’s Office of Generic Drugs. In order to be approved the drug must be comparable to the original drug in dosage, strength, route of administration, quality, effectiveness, and intended use. If it is proven that the generic drug performs at the same level as the brand name drug then they are not required to do additional clinical trails.

Additionally, Mylan expects the FDA to grant them 180 day exclusivity upon approval. This means that no other form of generic Copaxone could be released within 180 days of their generic drug, which gives them a marketing advantage.

Generic drugs have the same safety and effectiveness as the brand name drugs, but can differ in a couple of ways. First, the cost of generic drugs is an average of 80-85% lower then brand name drugs according to the FDA. Additionally, generic medications may have different binders, fillers, and coatings (for oral drugs) which can affect how fast the medication works, and if you can take them with food. Some patients may not respond as effectively to these ingredients, which is important to keep in mind when switching form a brand name to a generic medication.

You can find more information about generic drugs on the FDA's Question and Answer page here.

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