02 February 2018
Reporter: Barney Dixon

Changes to generic drug processes should be “carefully assessed”

Changes to generic and biosimilar drug approval processes should be “carefully assessed” to ensure that the development of new drugs is not undermined, according to Kevin O’Connor, partner at Neal Gerber & Eisenberg.

Kevin explains that “as the pharmaceutical landscape shifts from blockbuster drugs to more targeted therapeutics and precision medicine, it will remain as important as ever to balance the incentives for investment in innovative therapies with the desire to ensure competition after a reasonable period of exclusivity for the innovator product.”

At a recent US Federal Trade Commission workshop, US Food and Drug Administration commissioner Scott Gottlieb identified certain practices that delay generic entry may face increased governmental scrutiny.

The workshop focused on competition in the drug market and on strategies to encourage competition in order to lower prices and improve access.

According to Kevin, the workshop saw general agreement that it “continues to be important to protect intellectual property rights associated with new pharmaceuticals so that innovative companies have appropriate economic incentives to develop vital new drugs and undertake the costly work necessary to demonstrate safety and efficacy”.

But Kevin says that potential governmental scrutiny could harm incentives for pharmaceutical companies and potentially have a knock-on effect for innovation and should be carefully assessed before being implemented.

Subscribe for free to read the next issue of IPPro Patents, published on 7 February, to read this article in full.

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