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The agreement for the biologics site in Hangzhou is expected to close in the first half of 2021(Source:Shutterstock)

Pfizer has made the “difficult decision” to draw a line under its biosimilar endeavors in China, agreeing to sell its biologics manufacturing site in Hangzhou to local biologics contract development and manufacturing firm WuXi Biologics and halt its biosimilar programs in the country.

The agreement, which is expected to close in the first half of 2021, and new strategic direction followed “a comprehensive review of the biosimilars market and the company’s global manufacturing network,” a Pfizer spokesperson told Generics Bulletin. No financial details were disclosed.

After the transaction closes, WuXi Bio – which already possesses manufacturing facilities in Hangzhou – “will utilize the site to expand its local workforce and business operations to be able to start manufacturing much-needed biologics for its partners to benefit patients in China and across the world,” Pfizer added.

A little under five years ago, Pfizer announced plans to invest roughly $350m into its Chinese Global Biotechnology Center, based in the Hangzhou Economic Development Area, in order to construct a site with a total of six buildings housing R&D and production functions for innovative biologics and biosimilars. 

Biosimilar products under development at the time that were named as candidates for the China site included trastuzumab, bevacizumab, infliximab, rituximab, and adalimumab.

 

Meanwhile, Pfizer had also pledged to increase its investment to approximately $600m-$800m to bring further innovative monoclonal antibodies and vaccines into China at the site.

According to WuXi, Pfizer’s state-of-the art good manufacturing practice recognized site comprises 50,000 sq m of facilities, including drug substance capacities equipped with 2x2000L single-use bioreactors expandable to 4x2000L; and drug product capacities for vial filling and pre-filled syringes.

“Leveraging the facilities’ experienced workforce and WuXi Biologics’ extensive expertise in manufacturing and regulation, production is expected to commence shortly after the deal closure,” WuXi noted.

“We are pleased to work with Pfizer and add the new Hangzhou biologics manufacturing facilities to our global network to address the surging manufacturing demands for late-stage and commercial projects due to the success of our win-the-molecule strategy,” commented Chris Chen, WuXi’s CEO.

“Globally, drug substance and especially drug capacities are in urgent need now. The acquisition will allow us to better enable our global partners to develop and manufacture premier-quality biologics to benefit patients around the world.”

Pfizer China insisted that the transaction notwithstanding, it remained “committed to continuing to realize its purpose – breakthroughs that change patients’ lives in China.”

The US-based firm offloaded a material portion of its business in China when it spun out its Upjohn off-patent and mature brands business, which subsequently merged with Mylan to become Viatris. “We now have a significant and formidable presence in China,” Viatris CEO Michael Goettler recently told investors.

Nevertheless, Pfizer is continuing to spread its wings in China. Last year, the firm invested around $200m to obtain the rights to co-develop and exclusively commercialize Shanghai-based CStone Pharmaceuticals’ anti-PD-L1 antibody sugemalimab candidate, CS1001, in mainland China. 

Weeks later, Pfizer announced it was investing in and working together with the venture capital-backed LianBio to develop and commercialize pharmaceutical products in Greater China, under a plan to advance best-in-class therapies for patients, leveraging their combined clinical development, regulatory and commercial expertise. 

At the beginning of 2019, Pfizer shelved development of five pre-clinical biosimilars following a review, concluding that the research and development dollars would be better spent on the company’s pipeline of late-stage innovative programs. 

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