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FDA Official Tells China Biopharmas to Bring PD-1/PD-L1 Inhibitors to US
The Director of the US FDA's Oncology Center of Excellence, Richard Pazdur, MD, publicly urged China pharmas to bring their PD-1/PD-L1 inhibitors to the US market, saying they “could potentially be a great thing for everyone because we haven’t seen the major western pharmaceutical companies moving on price,” according to an article in BioCentury. He noted that six PD-1s have been approved in the US and “there are no differences in price.” Dr. Pazdur was speaking from the floor during the Q&A section of a recent American Association for Cancer Research meeting. Although the conference was in the US, the session was entitled "East meets West: Chinese pharma explores Western markets.”
Further, Dr. Pazdur promised China pharmas would have a fairly easy regulation process from the US FDA. The agency will approve a drug, including a PD-1/PD-L1 inhibitor, based solely on clinical data from China, he added. During a visit to China last summer, he was frequently asked if the FDA would accept applications with clinical data generated only in China. He responded: “The answer is yes, if it is good quality.”
Of course, Dr. Pazdur pointed out (in response to a question) that the FDA does not consider price when making regulatory decisions. However, he said the agency would welcome lower-cost PD-1/PD-L1 inhibitors.
For China pharmas with PD-1/PD-L1 inhibitors, the regulatory strategy is fairly straightforward, he added. Multinational pharmas have shown how to obtain the approvals, and China pharmas would need only to follow their strategies.
“I could see a very easy development strategy,” Dr. Pazdur said. “In lung cancer, for example, you could simply do the studies that the major pharmaceutical companies have already done. In fact, you already know the effect size to aim at, so these are very, very low-risk studies [that] could lead to full approval of these drugs.”
Continuing, Dr. Pazdur told Chinese companies: “You don’t have to do a non-inferiority study. You already know the effect size. There’s very little risk here.” He added that the statistical plan would be so easy to write “you don’t even have to be a statistician to do it.”
He also suggested that FDA approval of China PD-1/PD-L1 candidates based on development programs that mimicked FDA-approved products would be smooth. “Obviously, they could have very similar results, so we would have very little to say in the approval of these drugs.”
So far, four PD-1/PD-L1 inhibitors have been approved in China. Shanghai Junshi Biosciences Co. Ltd. (HK: 1877) priced its domestically developed anti-PD-1 mAb Tuoyi toripalimab at an 83% discount to the China price of Keytruda, a Merck (NYSE: MRK) drug that is priced in China at a 50% discount to the US price.
The other China developed and approved PD-1 is Innovent's (HK:1801) Tyvyt, which Innovent partners with Lilly (NYSE: LLY), though Innovent was responsible for developing the drug. It is more expensive, priced at a 56% discount to Keytruda’s price in China.
At a different AACR session, Dr. Pazdur continued his direct comments by asking representatives from Western biopharmas with marketed PD-1/PD-L1 inhibitors to explain why they aren’t collaborating more in the clinic and asking whether their respective molecules were “clinically” different.
November 18-20, 2019