GA HB1068

Reference product (brand-name biologic) license holders and entities marketing, selling, or distributing the reference product would be granted immunity from liability under Georgia law for claims arising from a patient's use of a biosimilar biological product, including interchangeable biosimilars

Immunity covers a broad range of claims including product liability (failure to warn, design defect, manufacturing defect), breach of warranty (merchantability, fitness, implied or express warranty), and all types of loss including death, physical/mental/emotional injury, fear of injury, need for medical monitoring, and property damage

Key terms—"biological product," "biosimilar," "interchangeable," "license," and "reference product"—are defined by reference to Section 351 of the Public Health Service Act (42 U.S.C. 262)

The immunity does not apply when the reference product license holder itself manufactures the biosimilar biological product in question

Amends Article 5 of Chapter 4 of Title 26 of the Official Code of Georgia Annotated by adding new Code section 26-4-81.1; sponsored by Representatives Weldon (3rd), Taylor (79th), Holt (112th), Battles (15th), Maddox (127th), and others