Pfizer Confirms That It Has Terminated 5 Preclinical Biosimilar Programs

A representative from Pfizer confirmed to The Center for Biosimilars^® that the company has terminated 5 of its preclinical biosimilar programs after the results of the company’s annual investment review.

The Pfizer representative said that the move is an effort to shift the company’s investment focus to deliver on the areas of “greatest potential for patients and investors,” and to reallocate the funding from the biosimilar programs in question to late-stage program across other key areas of research for the company. According to the representative, “This will support our ability to better allocate resources to cutting edge late-stage programs in disease areas where patients have only a few or no treatment options.”

In part, he indicated, the renewed focus on the company’s late-stage assets is due to the fact that the biosimilars would not have been available to patients “for at least 4 to 8 years.” However, he emphasized that Pfizer remains committed to biosimilars, with 3 US-marketed biosimilars—infliximab (Inflectra), epoetin alfa (Retacrit), and filgrastim (Nivestym)—and another 5 biosimilars in mid- to late-stage development.

In fact, during last week’s 37th Annual J. P. Morgan Healthcare conference, Pfizer’s president of worldwide research and development, Mikael Dolsten, MD, PhD, discussed Pfizer’s outlook for the coming years and said that, in 2019, a 4-product “biosimilar bundle” had a “potential registration opportunity” with blockbuster potential.

The biosimilar products that Pfizer continues to develop are PF-05280014, a trastuzumab biosimilar referencing Herceptin that was the subject of an FDA Complete Response Letter citing a need for additional technical information in April 2018; PF-05280586, a rituximab biosimilar referencing Rituxan; PF-06410293, an adalimumab biosimilar referencing Humira that was the subject of a recent settlement with Humira-maker AbbVie that will delay US market access for the biosimilar until 2023; PF-06439535, 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 PF-06881894, a pegfilgrastim biosimilar referencing Neulasta.

Pfizer’s cuts to its biosimilars program mirror similar changes in drug makers’ priorities in recent months; in late 2018, Momenta dropped 5 of its biosimilar programs, on which it was collaborating with Mylan. The company kept 2 late-stage programs—an adalimumab biosimilar and an aflibercept biosimilar—and Craig A. Wheeler, chief executive officer of Momenta, said in a presentation that the company expected to use the sales proceeds from the products to fund expensive phase 3 trials for novel rare disease drugs.

Also in late 2018, Merck terminated its agreement with Samsung Bioepis for a tentatively approved follow-on insulin glargine product referencing Lantus, citing challenges in bringing the product to market in the United States.