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Welcome to Generic Biotech Drugs. A generic biotech drug is a drug which is produced and distributed without patent protection. The generic biotech drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation.

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By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA’s use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired.

When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

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On the Brink of Generic Biotech Drugs, What’s the Cost to Innovation?

In a recently published report, the Federal Trade Commission suggested that the current allotment of a 12- to 14-year regulatory exclusivity period for product innovation to develop products at biotech companies is“too long to promote innovation.”

The same report, published June 4, also indicated that developing generic biotech drugs would help bring down the cost of U.S. health care. These less expensive versions are expected have prices discounts that are “between 10 and 30 percent of the pioneer products’ price,” the FTC said in its report, available here.

Shortly after report’s publication, President Barack Obama mentioned in a speech to the American Medical Association that creating a pathway at the FDA for approving generic biotech drugs would save the United States “billions of dollars.” But, as Arlene Weintraub was quick to point out in BusinessWeek, “How many billions? And how fast would those savings be achieved?”

With the advent of biotech generics, or follow-on biologics (FOBs), an impact on the economy is guaranteed, albeit unquantifiable. Industry insiders highlight that the biotech sector also stands to undergo some immeasurable changes itself.

“I am worried that the generic biotech companies make it less attractive to innovate,” said Mouli Cohen, entrepreneur and founder of Voltage Capital, a private equity innovation fund. Cohen’s firm invests in biotech startups and added, “Innovation and the ability to drive the process towards quantifiable outcomes is the hallmark of business in the U.S. Cannibalizing this process could reduce us to a mediocre player.”

Indeed, as PharmaTimes noted in reporting on the June 11 hearing by the House Energy and Commerce Subcommittee on Health, concerns have risen as to whether or not innovator biotech companies will be able to recoup their Research and Development investments, were FOBs were permitted to “come speedily to market.”

“R&D is increasingly expensive,” Cohen said. “The major pharmaceutical companies have reduced their efforts. This shifts the burden onto biotech and academia. In the end, someone or some entity has to sponsor the work. The cost will shift, but just like the medical system, the industry will break down if the compensation and the regulatory constraints become increasingly unfavorable.”

This means that biotech, although recently predicted by EvaluatePharma to achieve the largest growth of the any drug industry over the next five years, faces some massive obstacles in terms of funding.

“Two thirds of the future clinical pipeline for patients resides in small biotech companies – companies without profits, companies relying heavily on

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