Is pegfilgrastim a biosimilar?

There are currently 3 pegfilgrastim biosimilars on the US market. They include Udenyca (Coherus BioSciences), Fulphila (Mylan/Biocon), and Ziextenzo (Sandoz). Market size for pegfilgrastim is estimated at $3.6 billion. Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia.

Is pegfilgrastim generic?

Pfizer’s biosimilar pegfilgrastim Nyvepria was approved by FDA in June 2020 [7] and by EC in November 2020 [3]. Generics maker Sandoz received EC approval for Ziextenzo in November 2018 [3] and FDA approval in November 2019 [7].

What is the difference between biosimilar and generic?

Generic drugs are chemically identical to the original branded drug and, as such, cost significantly less because they don’t require much testing. Because biosimilars are made from living organisms, though, and don’t contain identical ingredients to their name-brand counterparts, they still require some testing.

Are biosimilars better than generics?

Biosimilars also have significantly higher research and development costs and risks and are more complex to manufacture than small-molecule generics. Biosimilars have the potential to provide additional treatment options at lower cost, but development requires significant investment.

What is another name for pegfilgrastim?

Neulasta is the trade name for pegfilgrastim. G-CSF is another name for pegfilgrastim. In some cases, health care professionals may use the trade name neulasta or other names G-CSF when referring to the generic drug name pegfilgrastim. Drug type: Pegfilgrastim is a biologic response modifier.

What is an example of a biosimilar?

An example of an approved biosimilar is Amjevita (adalimumab-atto), the first biosimilar approved for the blockbuster Humira (adalimumab) used to treat rheumatoid arthritis and psoriasis, among many other uses.

Why are biosimilars cheaper than biologics?

Biosimilars cost less because the path to their approval is shorter and cheaper. Manufacturers do not need to go through the same number of clinical trials and spend as much on research and development as biologics. That doesn’t make them any less safe, though.

Why are biosimilars better?

Biosimilars, like all biologics, are subject to inherent minor variability and may have minor differences in clinically inactive components, but are highly similar to the original product. Both biosimilar and generic drugs offer a potentially more affordable treatment option for some patients.

What is the difference between Neulasta and Fulphila?

by Udenyca and Fulphila are biosimilars of the reference product Neulasta (pegfilgrastim). The US Food and Drug Administration (FDA) approved Udencya and Fulphila as biosimilars of Neulasta in 2018, which means that each one is “highly similar to, and has no clinically meaningful differences from” Neulasta.

What is the alternative to Neulasta?

UDENYCA® (pegfilgrastim-cbqv) A Safe, Effective, and Affordable Alternative to Neulasta® (pegfilgrastim)