PharmaCare - Fertility Clinical Resource | Infertility Medication: Brand vs. Generic1-00
In one of the links I posted in previous message you can read the following:
Infertility Medication
Brand vs. Generic
What do FSH, HCG and HMG stand for?
FSH, HCG, and HMG are abbreviations for three different medications used to treat infertility. The following table summarizes generic and brand names that correspond to each abbreviation:
Abbreviation Generic Name Brand Name
FSH Follicle Stimulating Hormone
Gonal-F®, Follistim®, Fertinex®
HCG Human Chorionic Gonadotropin
Pregnyl®, Profasi®, Novarel®
HMG Human Menopausal Gonadotropins
Humegon®, Pergonal®, Repronex®
FSH stands for follicle stimulating hormone, which is contained in Gonal-F®, Follistim®, and Fertinex®. These medications are commonly used in combination with HCG in assisted reproductive technologies (ART). The function of FSH is to stimulate the growth of follicles in the ovaries.
Pregnyl®, Profasi®, and Novarel® all contain HCG or human chorionic gonadotropin. HCG is a hormone used to induce ovulation in women who are unable to ovulate on their own. It works by helping to release the egg from the follicle, usually following administration of FSH.
HMG stands for human menopausal gonadotropins, which helps to stimulate follicular growth and maturation. Humegon®, Pergonal®, and Repronex® contain HMG and are typically used in combination with HCG to induce ovulation. These medications are also prescribed for men who have insufficient quantity or quality of sperm due to hormonal abnormalities.
Why are there several different brand name medications corresponding to each generic name?
The medications that contain FSH differ by the way they are manufactured. Gonal-F® and Follistim® are both FSH produced through a complex bio-technical engineering process.
Gonal-F® and Follistim® differ from each other only slightly in regards to their chemical structure, but have the same action in the body. Fertinex®, on the other hand, is highly purified FSH collected from the urine of postmenopausal women.
The medications that contain either HCG or HMG are all made from identical active ingredients. For example, Pergonal®, released by Serono in 1985, was the first HMG product to be approved in the United States. After the patent expired for Serono to be the sole manufacturer of Pergonal®, Organon Inc. released Humegon® in 1994, and Ferring Labs. released Repronex® in 1997. Although medications containing HCG and HMG have brand names assigned by their manufacturers, they are still generic drugs. The manufacturers gave these drugs "brand names" as a way to differentiate their products from the other generic products. Therefore, all of the medications that contain HCG and all those that contain HMG are identical with the only difference being the manufacturer that produces that medication and the name assigned to their product.
Are generics less effective than brand name drugs since they are less expensive?
No, generic medications are made from the identical active ingredients as the corresponding brand medication. To further understand the equivalence of brand and generic medications, it is important to get an understanding of the process by which medications are approved.
For a new drug to be approved for marketing in the United States, the manufacturer must submit a new drug application (NDA) to the Food and Drug Administration (FDA). The NDA contains information regarding clinical tests that demonstrate the safety and effectiveness of a given drug in humans. These clinical trials performed with the new drugs can take a number of years.
In general, it takes millions of dollars for drug manufacturers to discover, research and develop a new drug. In order to recover from this financial investment, the federal government awards the manufacturer a 17-year patent for exclusive research and development (R&D) of the new drug. The patent prohibits other pharmaceutical companies from developing the same drug during that time frame. The purpose of this process is to encourage pharmaceutical manufacturers to continue R&D of new drugs.
Although 17 years is a long time, some drugs undergo many years of research and development before FDA approval. In 1984, the Drug Price Competition and Patent Term Restoration Act extended the manufactures exclusive marketing of the drugs for up to an additional 5 years, further encouraging new drug development by drug companies.
When the manufacturer’s patent expires, other drug manufacturers are then permitted to develop similar products that contain the identical active ingredients as the approved brand name drug. These are typically referred to as generic drugs. In order for generic forms of the brand name drug to be approved, they must meet the FDA’s stringent standards for equivalence (i.e., active ingredients, strength, chemical properties, ect.). When all of the standards of equivalence between the generic and the brand name drug are met, the FDA then approves the proposed generic drug for marketing in the United States.
Because the generic manufacturers did not have to invest heavily into R&D of a drug, they are able to offer their products at a reduced cost to the consumer. This explains why generics are much less expensive than their brand counterparts.
