As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The U.S. Food and Drug Administration (FDA) today announced action to make it faster and less costly to develop biosimilar medicines, which are lower-cost alternatives to expensive biologic drugs used ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Blau Farmacêutica, a Brazilian pharmaceutical company listed on Brazilian Stock Market (B3) and a regional leader in hospital pharmaceuticals with a strong presence across Latin America, announces an ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, MD, and CMS Administrator Mehmet Oz, MD, announced new FDA guidance aimed at making biosimilar drug development faster and less ...

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative ...

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline ...

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. This presents a golden opportunity for Contract Manufacturing ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The Food and Drug Administration is relaxing regulations on biosimilar drugs used for cancer and rare diseases in the hopes of boosting competition and lowering prices for high-cost pharmaceuticals.