Pfizer Halts Development of Five Preclinical Biosimilar Assets

Regulatory NewsRegulatory News | 15 January 2019 |  By 

Pfizer on Tuesday told Focus that it’s halting the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in mid- to late-stage development.

Joining a handful of other companies – from Boehringer Ingelheim to Momenta to Sandoz and more -- in exiting the US biosimilar space in some shape or form, Pfizer’s exit reiterates the need to raise questions about the viability of the US biosimilar market as a whole. 

“As a result from our recent R&D investment review that we conduct every year we decided to stop the development of five preclinical biosimilar assets which would not be available to patients for at least four to eight years, and reallocating the funding to late stage programs across Pfizer’s other key therapeutic areas of research,” Pfizer director of global media relations Thomas Biegi told Focus.

According to the Center for Biosimilars, the biosimilar products that Pfizer will continue developing are: a trastuzumab biosimilar referencing Herceptin that was the subject of an FDA Complete Response Letter in April 2018; a rituximab biosimilar referencing Rituxan; an adalimumab biosimilar referencing Humira that was the subject of a recent settlement with AbbVie that will delay US market access until 2023; a bevacizumab biosimilar referencing Avastin that recently gained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use; and a pegfilgrastim biosimilar referencing Neulasta.

Pfizer is still one of the leading biosimilar companies, and is locked in a lawsuit with Johnson & Johnson over its failure to gain market penetration for its Remicade (infliximab) biosimilar Inflectra (infliximab-dyyb). Pfizer also filed a citizen petition with FDA related to false and misleading information that has been spread about biosimilars.

As far as the companies that decided to pull away from biosimilars, in late 2018, Momenta halted five biosimilar programs in development with Mylan; Boehringer dropped all ex-US biosimilar programs in development; Sandoz halted its submission for biosimilar rituximab in the US after the Food and Drug Administration (FDA) requested additional information; and Oncobiologics announced in December 2018 that it was changing its name to Outlook Therapeutics and is no longer pursuing its bevacizumab and adalimumab biosimilars.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy