Developers of brand biologics are close to securing a win with the potential passage of healthcare overhaul legislation that includes provisions prohibiting generic competition for their products for 12 years. But companies hoping to make generic copies of these complex drugs haven't given up hope yet, according to the Wall Street Journal.
Healthcare reform legislation in both the Senate and House would, for the first time, set up an approval process for generic biologic drugs. But the bills would prevent generic copies for 12 years--longer than the seven years President Barack Obama proposed earlier this year. Brand companies have contended that without a sufficient period of exclusivity, the industry will have little incentive to invest hundreds of millions of dollars in finding innovative biologic medicines.
If the Senate passes its version, a House-Senate conference committee would be the final chance to change the language. The White House declined to say whether it will enter the fray, the WSJ notes. However, Ohio Democratic Senator Sherrod Brown says he will work to get the currently proposed exclusivity period reduced, according to PharmaTimes.
The 12-year provision has caused ire in the generic-drug industry."The Senate leadership had the opportunity to address the deficiencies of the House HCR bill. ...Instead, they have provided further hurdles to access more affordable medicines," Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, says in a recent statement.