The focus of Pfizer’s recent second quarter earnings call came as no surprise to PaizaBio, but was likely to have raised a few eyebrows from the investment community and among global pharmaceutical executives. Not only did CEO Ian Read announce that biosimilars are a key component of Pfizer’s growth strategy, he stated the global pharma giant is adding a new $350 million biologics plant as resident of a biotechnology center in Hangzhou, China, to be completed in 2018.
Of course, our first thought was “welcome to the neighborhood.” PaizaBio’s contract aseptic/injectable fill/finish operation is located in Hangzhou, China, a vibrant business region outside of Shanghai. Our second reaction was to nod: multinational pharmaceutical companies (MNCs) are waking up to the message that they need to be in China. Now.
Pfizer’s China biologic manufacturing entry strategy into China will employ GE’s KuBio pre-fabricated modular units, which allows for fielding such rapid operational capability. Taiwan’s JHL Biotech was the first mover in adopting this novel technological approach in manufacturing in their Wuhan, China, plant that formally opened in May.
As we have stated for more than a year, the future of the world’s pharmaceutical industry is in China. And it’s not merely the fact that China has 1.4 billion potential healthcare consumers. China is transforming its national healthcare system in an effort to bring access to more affordable care and drugs throughout China. It has also announced and is feverishly implementing a slew of new policies intended to speed the approval process of innovative drugs, foster domestic clinical drug development and manufacturing capabilities, to global quality standard; reforming marketing and commercialization practices, all while lower the overall price of drugs.
Pfizer, which is a worldwide leader in biosimilars, has recognized that to expand its footprint in China, it must play by the new rules: manufacture in China and price its products to China’s new standards. This is the only objective pathway presented by the CFDA in its new Fast Track drug approval policies and facilitated via its new Marketing Authorization Holder policies.
China represents an unprecedented opportunity for Big Pharma and particularly for those with biosimilar biologics strategies, with this caveat: you must manufacture in China to achieve rapid regulatory review.
PaizaBio is currently performing contract fill/finish services to MNCs and Chinese companies in China. We are also preparing the technical workforce to Western standards at our sterile university, the Trans-Pacific Aseptic Institute of Training™. Only PaizaBio can fast track your entry into China to China’s rules.