In recent years, generic drugs have become readily available and typically provide the same therapeutic outcomes as traditional brand name drugs. According to the FDA, a generic drug is chemically identical to a brand name drug in dosage form, strength, method of administration, quality, performance characteristics and intended use. Generics have the same active ingredients as their brand name counterparts. Each new generic drug is reviewed and approved by the FDA. When compared to brand name drugs, the costs of generics are substantially lower.
As of 2019, 45 states and Puerto Rico have established legislation that sets standards for substitution of a “biosimilar” prescription product to replace an original biologic product. Another four states are considering such legislation. As of December 2019, 23 biosimilars have been approved by the FDA.
What Are Biosimilars?
As part of the Affordable Care Act (ACA), the government created an abbreviated licensure pathway for biologic products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product. The biosimilar product must show that it is highly similar to an FDA-approved biologic product, with no clinically meaningful differences in terms of safety and effectiveness. Only minor differences in clinically inactive components are allowable in biosimilar products, but they are not interchangeable like traditional generic to brand name drugs. It is important that an interchangeable biological product is biosimilar to an FDA-approved reference product and meets additional standards for interchangeability.
Biosimilars have been readily available in Europe for several years at significant cost savings. This is also due to the state controlled pricing authority in the European Union and many other countries. It was hoped that specialty drug costs would decline considerably with the introduction of competition from other patented drugs or biosimilar drugs after the patents expire. However, cost savings from biosimilars have shown to be less than expected with approximate savings in the 10%-15% range. There are still major challenges ahead for biosimilars, including the complexity and cost of development, approvals to get them into the market, and patient protection delays from existing biogics. With only a handful of biosimilars on the market today it’s anticipated this number will grow as brand name drugs continue to go off patent.
2017-2018 is anticipated to be a bigger roll-out timeframe for biosimilars, but many of these proposed drugs may face patent or legal decisions that slow their market entry. The new Trump administration could also slow or accelerate approvals and uptake. In addition, it is unknown if physicians will feel comfortable prescribing biosimilars, knowing they are not an exact replica of the drug it is intended to replace.
Other Terms for Biosimilars
The following terms exist for biosimilars but are not as common, scientifically or regulatorily accurate. These include:
Biogeneric: Follows the existing FDA drug regulatory approval pathway for an identical drug. This is usually accomplished through human clinical trials or more recently through sophisticated computer modeling of the biologic drug chemical structure compared to the branded original product, usually from small sized drug molecules like insulin. Sometimes this is referred to as a biosimilar product in marketing information but is not considered a true biosimilar product by legislation.
Biobetters: Instead of being a structural imitation of an existing biologic product, biobetters has other manufacturing similarities to the original product. These are also tested in human clinical trials but considered “branded generics” due to the lack of identical entity or formulation but they may use the same basic drug molecule structure. These drugs might offer an easier route of administration or less frequent dosing. Sometimes a biobetter is also referred to as a biosimilar product in marketing information.
Learn more about biosimilars and the marketplace.