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Generic manufacturers can benefit from QbD but fears it will hinder companies in the race to be first-to-file are slowing progress, a VP at Teva said.
Quality-by-Design (QbD) has gained traction among innovator companies but adoption has been slower in the generic sector. When looking to adopt QbD principles generic players must offset the efficiency gains against the risk the extra work will mean a competitor wins the race to be first-to-file.
“If you’re not first to file you may as well be last”, Yatindra Joshi, vice president of generics research and development at Teva, said at a US Food and Drug Administration (FDA) committee meeting . Coming second can mean a $100m (€70m) opportunity withers to just a few million dollars.
In this environment it can be hard to justify the extra initial time and work QbD requires but, said Joshi, it is clear to the generics industry that it must implement the methods. Joshi raised the idea that the FDA could “level the playing field” by making some elements of QbD mandatory in filings.
A 2009 McKinsey & Company report commissioned by the FDA also raised this point, noting: “There may be a good argument to make QbD a mandate for some types of generic filings.” The report also found generic players lag behind their small molecule innovator counterparts in adopting QbD.
Although a QbD in generics is yet to be mandated Joshi praised the US Office of Generic Drugs (OGD), particularly for partnering with the Generic Pharmaceutical Association (GPhA) to develop guidelines.
OGD actions
At the same committee meeting the FDA gave an update of QbD activities at the OGD and its talks with industry. “At this point industry feedback has focused on use of prior knowledge and risk analysis”, Sarah Pope Miksinski, branch chief at the FDA office of new drug quality assessment, said.
All abbreviated new drug applications (ANDA) are being submitted in Question-based Review (QbR) format and some submissions are already including QbD elements. To handle the expected QbD ramp up the OGD is conducting internal training later this year and will continue talking to industry.
The revised QbD review system is to be fully implemented by January 2013.
