Overview

At Tanvex, we pride ourselves on a proven track record that spans the entire lifecycle of drug development—from pre-clinical to Investigational New Drug (IND), Biologics License Applications (BLA), and successful commercialization. With a U.S. FDA and Health Canada approved biosimilar, our commitment to quality, innovation, and rigorous regulatory compliance positions us as a trusted partner in the pharmaceutical landscape.

  • Product expertise includes pre-clinical phases to post-marketing surveillance
  • Successful U.S. FDA and Health Canada approvals for biosimilars
  • Commitment to stringent quality standards throughout all stages of product development
  • Dedication to improving patient outcomes and access to therapeutic treatment options
View Approved Products

Pipeline

Tanvex is exploring biosimilar pipeline opportunities across therapeutic areas, including oncology and immunology. Our current developments include:

Ref Molecule innovator pre-clinical phase I phase III submission approval
NYPOZI™
filgrastim
Neupogen® (Amgen)
TX-05
trastuzumab
Herceptin® (Roche)

Biosimilars

Our products are approved in individual countries for specific uses and the information provided is governed by local regulations. Product availability, name, and indicated use may vary by country. The biosimilar information provided in our Product Database is intended for residents of the US and Canada only.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

FDA Biosimilar Resources

Biosimilars are safe, effective treatment options that increase access to lifesaving medications, and potentially lower health care costs through competition. The following educational resources are provided by the U.S. Food & Drug Administration.