Samsung Bioepis, a company developing biosimilars and new drugs, announced the interim results of its phase 1 and phase 3 clinical trials for a biosimilar (a copy of a biologic drug) of MSD’s Keytruda ...

Celltrion announced on July 15 that it has received approval from the Ministry of Food and Drug Safety for its ...

Celltrion has received approval to begin a domestic Phase 1 clinical trial for CT-P68, a biosimilar of the autoimmune ...

The government is dramatically easing requirements for Phase 3 clinical trial and animal testing data submissions for ...

In today's ACT Brief, we examine how FDA's single pivotal trial shift raises recruitment and retention stakes, why FSP should ...

Ten years after the first etanercept copy reached European patients, the EMA, real-world registries and rheumatologists have ...

Biocon Limited (BSE: 532523; NSE: BIOCON), an innovation‑led global biopharmaceutical company, today announced the publication of two important clinical studies supporting the effectiveness of ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

NEW TAIPEI CITY, June 10, 2026 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed ...

GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera Solutions (688177.SS), a commercial-stage biopharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the ...

Patent litigation reform could accelerate US biosimilar market entry, which lags behind the EU due to protracted legal processes. Biosimilar manufacturers face options like pre-clearance, "at-risk" ...

U.S. regulators have proposed loosening some of the clinical trial requirements for companies to win approval for biosimilar versions of insulin products ...