FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
1/14/2025
/ Biosimilars ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regulatory Approval ,
Regulatory Requirements
The United States Patent and Trademark Office (USPTO) announced today the finalized fee increases taking effect on January 19, 2025. While applicants can still expect significant increases in certain areas, some proposed fee...more
11/20/2024
/ Applications ,
Corporate Counsel ,
Disclaimers ,
Duty to Disclose ,
Fees ,
Information Disclosure Statement ,
Patent Applications ,
Patent Ownership ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patentability Search ,
Patents ,
USPTO
Heading into 2025, patent applicants should prepare for significant fee increases at the United States Patent and Trademark Office (USPTO). These fee increases can significantly impact patent applicant behavior, leading...more