Hatch-Waxman & Biosimilars

When it comes to the intricacies of the Hatch-Waxman and Biosimilars processes, HPM’s attorneys understand how important the details, especially timing, can be for your business.  Our attorneys have extensive experience navigating the abbreviated approval pathways for both prescription drugs and biologics, and we can help you make sure that all your t’s are crossed and your i’s dotted.  From developing a bioequivalence strategy to drafting your patent certifications to carving out labeling language to filing Citizen Petitions, HPM can assist you through the entire premarket notification and application process.

Our attorneys have experience with the intricacies of the NDA, ANDA, 505(b)(2), BLA, and aBLA application.  HPM has analyzed the Biologics Price Competition and Innovation Act and understands the differences and similarities between biosimilar requirements and small molecule requirements.  HPM can help ensure that your submission is filed at the proper time to obtain exclusivity, navigate or obtain market exclusivities or patent term extensions, understand listings in the Orange Book or Purple Book, evaluate the regulatory status of potential products or competitors, and develop a strategy for any necessary revisions.  After submission, HPM can assist with dispute resolution, postmarketing reports and updates, supplements, and product discontinuation.