The "interchangeable" designation has created confusion around the difference between biosimilars designated as interchangeable and those that are not.
A Bill signed today allows waivers of animal testing for new drugs and biosimilars, a major shift in how the drug development with lower cost and better safety.
Ryan Blaney practices privacy law, and represents health care, life science, and technology clients in regulatory, enforcement, investigative and transactional matters. Blaney also counsels clients on health care fraud and abuse, third party reimbursement, data breach issues, data privacy and more.
On Aug. 11, 2021, the United States Patent and Trademark Office (USPTO) published an update to its 2019 Orange Book (OB) patent/biologic patent study report, analyzing America Invents Act (AIA).