1) What are Generic Medications?
Generic medications are drugs that are equivalent to the original, or "name brand" drug. Given the fact that the formula or recipe for the API (active pharmaceutical ingredient) is known, the cost of developing a generic medication, gaining regulatory approval, and production of the final medication is several-fold cheaper than the original version.
2) What is the Active Pharmaceutical Ingredient?
The API is the part of a pill or capsule that is that actual "medication". The remaining parts of the pill or capsule allow for the medication to be swallowed, and absorbed into the body, allowing for the API treatment effect to take place.
3) Does a generic medication work in the same way as the original medication?
The FDA offers the following definition: a generic drug is identical--or bioequivalent--to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm)
4) What are the advantages of using a Generic Medication?
The main advantage is that the generic drug is cheaper for the patient. Since cost is the largest barrier to care for most men, especially when it relates to treatments for ED and BPH, having a safe and effective option that is affordable greatly improves the chances that a man will access effective treatments. From a societal standpoint, the Congressional Budget Office in the United States estimates that generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. The cost savings trends are similar in Europe, Canada, and indeed globally. However, many geographical areas do not have sufficient access to generic medications, including regions in the European Union.
5) How large is the generic drug market?
Estimates vary, as trends support ever-increasing utilization of generic medications globally. The IMS Institute for Healthcare Informatics reports spending on medicines will reach nearly $1,100Bn in 2015, with generics accounting for $400-430 Bn.
6) How has government policy effected the generic and branded medication markets?
There has been a legislative change globally with longer-term impacts on the spending and usage of medicines across many countries including the passage of the Affordable Care Act in the U.S., a sweeping reform of Japan’s unique every-other-year price-cut system, and several new reforms to rebalance spending priorities in each major European market. Important steps were also taken in the U.S. and Europe in the development of scientific guidelines for the approval of biosimilars. Each of these serves to support the use of safe, equivalent, generic medications whenever possible.
What is the current 'big picture view' for generics?
Today, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. The EU is not at this level currently, but growth forecasts are consistently revised upwards as global governmental authorities and third-party payers are working towards controlling health-care expenditure costs while maintaining excellence in patient care.
7) How is a generic drug approved?
The process is clearly delineated, and regulated by respective authorities in the European Union, the United States, and Canada. For Europe, drug approvals may be obtained on a country-by-country basis, or more commonly and cost-efficiently, EU-wide. The key aspects of approval include ensuring the generic drug contains the same active ingredients (API) as the innovator or branded drug (inactive ingredients may vary) and is identical in strength, dosage form, and route of administration (which may include pills, capsules, injections, or suppositories).
The patient may only use the generic drug for the same 'use indications', and the generic pharmaceutical manufacturers must show bioequivalence, meet the same batch requirements for identity, strength, purity, and quality, and be manufactured under the same strict standards of good manufacturing practice regulations required for innovator products as per EMEA, FDA and Health Canada.
8) Do generic medications work?
Generic medications are made to be equal to the originator medication. A generic drug is a copy of a brand name product, also known as the 'reference product', contain the same medicinal ingredients as the brand name drug, and are considered bioequivalent to the reference product.
In order to gain regulatory approval and to prove that their products are safe and effective, generic drug manufacturers must demonstrate that the generic drug performs similarly to the brand name drug.
Regulatory bodies review the studies that compare the generic drug with the brand name drug, which are named "comparative bioavailability" studies. The level of a medicinal ingredient in the blood of healthy human volunteers is measured as each subject gets the brand name drug and the new generic drug. In order to gain approval, the generic drug must show that it delivers the same amount of medicinal ingredient at the same rate as the brand name drug.
9) How many different forms of an originator or reference drug may be approved?
There may be many generic versions of the same reference product. In many cases, there are several generic manufacturers for a safe and successful originator medication as the consumer market can and will support the manufacturers. In many countries, generic medication availability may be limited for a particular drug and offer tremendous business opportunities.
10) Where can I find out more about generic medications?
The Biopharmcor website offers an accompanying slide presentation, as well as complimentary information specific to the company's strategic Men's Health centered vision. External links specific to generic medications may by found on the the FDA website (http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm), the European Medicines Agency (http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000335.jsp&mid=WC0b01ac0580514d5c), and Health Canada (http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/med-gen-eng.php).