In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...

Aydin Harston Ph.D., Alexander Shaver Ph.D. FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.

Teva Pharmaceuticals Stock: Unlock Value in This Generic Drug Gem Alvotech (NASDAQ:ALVO) Chief Strategy Officer Balaji Prasad ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

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 ...

BEECH ISLAND, S.C.--(BUSINESS WIRE)--Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a ...

A March 9 draft guidance from the FDA proposes an allowance for biosimilar sponsors to use clinical data from outside the U.S. to seek the agency’s approval, which would reduce the requirement of at ...

The increasing demand from government agencies, insurers and patients to reduce the steep cost of blockbuster biopharmaceutical products has created considerable opportunities in the global biosimilar ...

Merilog 100units/mL is supplied as both a 10mL multi-dose vial as well as a 3mL single-patient-use prefilled pen. The Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj), a ...