Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Samsung Bioepis. News release: Samsung Bioepis obtains first drug approval in the United States, as the U.S. Food and Drug Administration approves Renflexis (infliximab-abda) across all eligible indications. 2017 Apr 24.
2. Radius Health. News release: FDA approves Radius Health’s Tymlos (abaloparatide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high risk for fracture. 2017 Apr 28.
3. U.S. Food and Drug Administration. FDA Drugs @FDA: Prescribing information Tymlos (abaloparatide). 2017 Apr 28.
4. Hattersley G, Attalla B, Varela A, et al. Comparison of osteosarcoma incidence between abaloparatide (BA058) and PTH (1-34) in long term rat studies. Bone Abstracts. 2014;(3):302. doi:10.1530/boneabs.3.PP302.