In a bid to allay conflict-of-interest concerns, Korean manufacturing giant Samsung Biologics is decoupling from its ...

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone ...

Samsung Biologics, a biotech arm of South Korea's Samsung Group, said Thursday it plans to spin off its biosimilar ...

Accelerate Polpharma Biologics biosimilar program from IND to commercial manufacturing Includes a commitment to producing for US FDA BLA submission Expand global market presence through launch in ...

Feldman and Schor explain that the patent dance is a complex process to determine which of a biologic manufacturer’s patents ...

Number 3: Sarfaraz K. Niazi, PhD, asserts that India's recently revised 2025 biosimilar guidelines represent a significant and rational step towards global regulatory alignment by deemphasizing animal ...

South Korean drug maker Samsung BioLogics said on Thursday it plans to split its business into contract manufacturing and development companies, to help allay customer concerns about conflicts of ...

Biocon Biologics, a subsidiary of India-based Biocon Ltd, said on Thursday that U.S. FDA has approved Jobevne, a biosimilar of Roche's bevacizumab for intravenous use. Jobevne, a vascular ...

From the creation of a regulatory pathway for biosimilars in the EU only three biologics experienced EU biosimilar competition until the launch of Remsima/Inflectra in 2013, and none have (as at ...

BRIDGEWATER, N.J., and BENGALURU, India, March 7, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars ... secondary outcomes related to safety, tolerability ...