More Clinical Trials in China in the Future?

The China Food and Drug Administration (CFDA), which became a regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in June 2017, is now moving forward with the implementation of several ICH guidelines in order to further the development of innovative drugs and devices in China, and align with global regulatory standards in manufacturing and development.

China’s implementation of the ICH guidelines will not only help ensure that global standards of quality and safety are met but can help reduce drag on pharmaceutical companies’ timelines by streamlining various processes such as clinical trial application and approval. Additional reforms will likely increase the number of Chinese hospitals and research centers able to manage clinical trials without having to undergo an extensive certification process.

These ICH-driven reforms will likely provide US pharmaceutical companies with greater opportunities to include China in global clinical research as well as greater access to the Chinese markets. As a member of ICH, China will be expected to continue implementing regulatory requirements for the manufacture and testing of study drug products. We expect to see an uptick in the conduct of clinical trials once the controls are in place to ensure that quality, safety, and efficiency is consistent across the Chinese markets.

We at Contracts Associates are looking forward to the further integration of China’s prominent researchers into our global clinical trials.

FDA suddenly adds four-letter meaningless suffixes to new biologics’ nonproprietary names

Back in 2015, the FDA implemented a policy which required the addition of suffixes to biosimilars. On June 1 2016, the FDA suggested that sponsors could provide the FDA with up to 10 preferred proposed suffixes for its biosimilars and that the FDA would then choose which preferred suffix met its guidelines. Sounds like a good policy, right? Companies get to suggest their favorite “baby” names and the FDA picks one it likes. Well, the FDA withdrew that plan on June 20, 2016.

However the suffixes for biosimilars have been chosen since June 2016, it was clear that the FDA only applied this requirement for suffixes (which makes sense for biosimilars, so that consumers can tell them apart and doctors can report adverse events) to biosimilars. For example, Sandoz’s Zarxio’s nonproprietary name is “filgrastim-sndz”. Totally logical so far.

On November 16, 2017, the FDA approved Genetech’s hemophilia A biologic Hemlibra (good news for patients!) and assigned it a random suffix of “kxwh” (emicizumab-kxwh).    In the absence of published public comments (which would be published in the Federal Register) and/or the announcement of a policy decision, one has to assume that assigning these suffixes to all new biologics will be the law of the land.

We know the time an effort industry sponsors put into branding their biologics and we imagine that random characters appended to the end of such a carefully-considered name is not the most welcome of surprises. The FDA typically provides sponsors with substantial notice prior to making substantive policy changes (it is a government agency after all!); however, this sort of abrupt implementation of policy may be our new normal.