Authors

Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).

What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation.

The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.

As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.

The biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.

Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.