Biosimilars Policy, Accelerating Medical Breakthroughs Among Year's Key Topics
- Bronwyn Mixter and Dana A. Elfin
- Pharmaceutical Law & Industry Report
Gaby L. Longsworth, Ph.D., was quoted in a recent Pharmaceutical Law & Industry Report article discussing the key issues that biotech and pharmaceutical companies will face in 2015 when dealing with new and changing patent policies.
A key topic is the predicted rise of inter partes review (IPR) proceedings in the biosimilars space. "So far most IPRs in the pharma space have been filed on small molecules as an alternative or in conjunction with Hatch-Waxman litigation," Dr. Longsworth says. "As more aBLAs [abbreviated biologics license applications] are being filed, we can expect to see IPRs for biologics/biosimilars and biotech patents in a BLA [biologics license applications] context."
Dr. Longsworth also predicts that 2015 will bring more mergers and acquisitions of innovator pharmaceutical companies by generics. "Hybrid companies are the wave of the future," she states.
To read the full article, download the attached PDF.