Richard Pazdur, director of FDA’s Oncology Center of Excellence, is urging Chinese companies to bring PD-1/PD-L1 inhibitors to the U.S. market and undercut the prices charged by multinational pharmas.
Chinese companies competing in the U.S. on the price of PD-1s “could potentially be a great thing for everyone because we haven’t seen the major western pharmaceutical companies moving on price,” Pazdur said at the American Association for Cancer Research meeting. He spoke from the audience during the question and answer portion of a session titled “East meets West: Chinese pharma explores Western markets.”
FDA could approve a drug, including a PD-1/PD-L1 inhibitor, based solely on clinical data from China, Pazdur said. He reported that on a visit to China last summer, he was frequently asked if FDA would accept applications with clinical data generated only in China. “The answer is yes, if it is good quality.”
He said he was also asked if FDA considers price when making regulatory decisions. Pazdur said FDA does not consider price, but he also made it clear that the agency would welcome lower-cost PD-1/PD-L1 inhibitors.
He noted that six PD-1s have been approved in the U.S. and “there are no differences in price.”
FDA has approved six PD-1/PD-L1 inhibitors from seven companies for nearly 50 indications: Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), Tecentriq atezolizumab from Roche (SIX:ROG; OTCQX:RHHBY), Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE), Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Libtayo cemiplimab-rwlc from Regeneron Inc. (NASDAQ:REGN).
Multinational pharmas have created a playbook for PD-1s that could streamline the development of competing products, according Pazdur.
“I could see a very easy development strategy,” he 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.”
Warming on the theme, 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 Chinese PD-1s 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.”
Chinese manufacturers have already launched PD-1s in China at substantial discounts to competing products from multinational pharmaceutical companies.
For example, in January Shanghai Junshi Biosciences Co. Ltd. (HKSE:1877) priced its domestically developed anti-PD-1 mAb Tuoyi toripalimab at an 83% discount compared with the China price of Keytruda.
Another Chinese company, Innovent Biologics Inc. (HKSE:1801), set the price of its anti-PD-1 mAb Tyvyt sintilimab (IBI308) at a 56% discount compared with Keytruda’s price in China.
Innovent is co-developing Tyvyt in China with Eli Lilly and Co. (NYSE:LLY). The mAb was approved by China’s National Medical Products Administration in December for relapsed or refractory classical Hodgkin lymphoma (see “China’s NMPA Approves Innovent’s PD-1 mAb Tyvyt for Hodgkin Lymphoma”).
The AACR “East meets West” session was moderated by Joshua Berlin, executive director of new ventures at BioCentury. Speakers included Dan Zhang, executive chairman of Chinese CRO Fountain Medical Development Ltd. (Beijing, China), Frank Jiang, chairman and CEO of immuno-oncology company CStone Pharmaceuticals Co. Ltd. (HKSE:2616), and Joan Shen, head of R&D at I-Mab Biopharma (Shanghai, China).
On a separate AACR panel, Pazdur pressed representatives from Western companies with marketed PD-1/PD-L1 inhibitors to explain why they aren’t collaborating more in the clinic and whether their respective molecules were “clinically” different (see “Pazdur Grills PD-1/PD-L1 Companies Over Lack of Collaboration, Trial Redundancies”).
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