The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the ...

Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could ...

The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)(1) , a sweeping guidance that codifies multiple regulatory ...

FDA looks further ease biosimilar approvals by allowing foreign clinical data and reducing pharmacokinetic study requirements to cut costs.

A >500-patient, randomized, double-blind phase 3 trial showed CT-P43 achieved PASI 75 equivalence at week 12 versus ustekinumab under standard induction and q12w maintenance dosing. Durability through ...

The MarketWatch News Department was not involved in the creation of this content.-- The agreement covers up to five assets, including SB36, a biosimilar candidate referencing Enty ...

Rising Cancer Incidence and Patent Expirations Drive Demand for Affordable, Accessible Biosimilars, Revolutionizing Global Oncology Care”Boston, March 17, 2026 (GLOBE NEWSWIRE) -- According to the ...

Sandoz announced the creation of a new biosimilar development, manufacturing and supply unit that will be headed by industry veteran Armin Metzger, who will join Sandoz on April 1.

Sandoz has not minced words about the massive, yet largely untapped opportunity biosimilar makers are presented with as dozens of branded medicines inch toward the patent cliff in the next decade.& | ...

As hospitals reduced their spending on oncology treatments due to the increasing availability of biosimilars, the reimbursements they received from insurers did not drop at the same rate—allowing h | ...