Most people agree that a generic biologics pathway for the U.S. Food and Drug Administration (FDA) approval of these drugs would be a boon to consumers, but different parties seem to be at odds on the exact exclusivity period that the pharmaceutical companies should be given from their generic drug competitors.

These generic biologics are known as biosimilars (or also, follow-on-biologics and biogenerics). If a pathway for these life-saving drugs to gain approval by the FDA could be forged, it could potentially save consumers a great deal of money, as these cutting-edge drugs are generally tremendously expensive.

If you are familiar with the Hatch-Waxman Act, you might wonder why biosimilars do not share the same FDA approval pathway that other conventional drugs go through to gain entry into the market. Simply put, biologics are different. They are larger, significantly more complex compounds that are derived from living organisms whereas conventional drugs are smaller, less complex, and are chemically synthesized.

Currently there is no pathway for these biosimilars to gain FDA approval. However, there have been a number of attempts to pass legislation relating to biosimilars, notably H.R. 1427 and 1548, two competing bills before the House, and S. 726, a companion bill to H.R. 1427, which is before the Senate.

One of the greatest points of contention in reviewing these bills has been the exclusivity period that should be granted to the drug companies before the biosimilars can enter the market. Unsurprisingly, brand name drug and biotechnology companies argue for longer exclusivity periods, about 12-14 years, asserting that a shorter exclusivity period would endanger incentives for innovation. Consumer groups and other advocates argue for shorter exclusivity periods, noting that a longer exclusivity period would mean a longer delay before consumers could get their hands on these more affordable, life-saving drugs.

The brand name drug companies seem to be faring better in this regard. H.R. 1427, which provides for a 12-year exclusivity period, has more cosponsors than H.R. 1548, which provides for a 5-year period. Furthermore, the Senate health committee voted favorably for an exclusivity period of 12 years, a period closer to the 12-14 years drug companies sought as compared to the 7-year period endorsed by the Obama administration and the 5-year period supported by consumer groups.

Despite the heated arguments on the exclusivity period, both the competing bills have the same goal–to provide a pathway for FDA approval of biosimilars and consequently increasing affordability for consumers. But in order to determine the proper exclusivity period, Congress will have to balance the incentives for innovation with the benefits of more quickly creating biosimilar accessibility to consumers.

Christine You

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One Response to Biosimilar Bills Foment Heated Debate

  1. harlan says:

    7 years is plenty long enough for big pharma to make a significant profit.They spend millions in research and make billions in profit.Consumers have a right to have more and cheaper choices whether it is drugs or OTC herbs and medications.Big pharma wants to control as much as it can,keeping prices high and profit high.This is another reason medical insurance is so high and costly.An example,generic at Wal-Mart 4 dollars,original depending on brand,10 to 30 times higher.